Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

AUDIENCE: Emergency Medicine, Pediatrics

ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.

RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall Notice and press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258133.htm

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

AUDIENCE: Emergency Medicine, Pediatrics

ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.

RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall Notice and press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258133.htm

What's New on the FDA Drugs Site

June 7, 2011

BPCA/Pediatric Exclusivity Statistics
Pediatric Exclusivity Granted (updated)
Pediatric Exclusivity Statistics (updated)
Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
MedWatch Safety Alert: American Regent Injectable Products: Recall - Visible Particulates in Products (updated)
National Drug Code Directory (updated)
NDC Product File Definitions (updated)
NDC Package File Definitions (updated)
June 6, 2011

Guidance for Industry: Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB)
New and Generic Drug Approvals

June 7, 2011

Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
Corgard (nadolol) Tablets, King Pharmaceuticals Inc., Labeling Revision
Corzide (bendroflumethiazide and nadolol) Tablets, Pfizer, Inc., Labeling Revision
Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
Losartan Potassium Tablets, Huahai US Inc., Approval
Macrobid (nitrofurantoin and macrocrystaline) Capsules, Almatica Pharma, Inc., Labeling Revision
Macrodantin (nitrofurantoin macrocrystals) Capsules, Almatica Pharma, Inc., Labeling Revision
Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Approval
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Approval
Zolpidem Tartrate Extended-Release Tablets, Actavis South Atlantic LLC, Approval
Zolpidem Tartrate Extended-Release Tablets, Synthon Pharmaceuticals, Inc., Approval
June 6, 2011

Diovan (valsartan) Tablets, Novartis, Labeling Revision
Letrozole Tablets, Synthon Pharmaceuticals, Inc., Approval
Letrozole Tablets, Fresenius Kabi Oncology, Approval
Letrozole Tablets, Endo Pharmaceuticals, Inc., Approval
Letrozole Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Letrozole Tablets, Roxane Laboratories, Inc., Approval
Letrozole Tablets, Natco Pharma Ltd., Approval
Letrozole Tablets, Accord Healthcare, Inc., Approval
Letrozole Tablets, Impax Laboratories, Inc., Approval
Letrozole Tablets, Sun Pharmaceutical Industries Ltd., Approval
Letrozole Tablets, Kudco Ireland Ltd., Approval
Letrozole Tablets, TEVA Pharmaceuticals, Approval

What's New on the FDA Drugs Site

June 3, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
Drug Shortages: Current Drug Shortages: Foscarnet Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
Drug Shortages: Current Drug Shortages: Intravenous Fat Emulsion (updated)
Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
Drug Shortages: Current Drug Shortages: Metoclopramide injection (updated)
Drug Shortages: Current Drug Shortages: Multi-Vitamin Infusion (Adult and pediatric) (updated)
Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4% (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Phosphate Injection (updated)
Drug Shortages: Current Drug Shortages: Tromethamine (updated)
Drug Shortages: Current Drug Shortages: Vecuronium Injection(updated)
Drug Shortages: Current Drug Shortages: Vincristine Sulfate Injection(updated)
MedWatch Safety Alert: Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
Office of Translational Sciences (updated)
New and Generic Drug Approvals

June 3, 2011

Banzel (rufinamide) Oral Tablets, Eisai, Inc., Labeling Revision
Banzel (rufinamide) Oral Suspension, Eisai, Inc., Labeling Revision
Clindamycin Hydrochloride Capsules, Matrix Laboratories Ltd., Approval
Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Donepezil Hydrochloride Tablets, Apotex Inc., Approval
Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision
Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision
Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals, Labeling Revision
Retisert (fluocinolone acetonide) Implant, Bausch & Lomb, Inc., Manufacturing Change or Addition
Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Approval
Venlafaxine Hydrochloride Extended-Release Capsules, Torrent Pharmaceuticals Ltd., Approval
Tussionex Pennkinetic (chlorpheniramine polistirex and hydrocodone polistirex) Extended-Release Oral Suspension, UCB, Inc., Approval

Uppsala Monitoring Centre Newsletter Issue nr 2, June - 2011

The second quarter of 2011 is here and the Uppsala Monitoring Centre’s new Drug Dictionary China will be launched, the upcoming WHO Drug Dictionary User Group Meeting will take place in Brussels, the UMC continues to develop new SDGs and lastly we would like to inform you about the Japanese Cross Reference Tool.


The New Drug Dictionary China – The Code to China

It is now here. The new Drug Dictionary China, which translates Chinese character medicinal product names into the WHO DDE global coding system. This conversion gives you direct access to a collection of up-to-date medicinal product information and analytical tools which is contained within the WHO DDE for drugs used in China; it also includes Traditional Chinese Medicines.
A world premiere for the new Drug Dictionary China is going to be held at the 47th DIA Annual meeting in Chicago, IL on June 19-23, 2011.
Come and meet us in Chicago!
Read more about the new Drug Dictionary China www.CodetoChina.com


The WHO Drug Dictionary User Group Meeting in Europe Brussels

The WHO Drug Dictionary User Group Meeting in Europe will take place in Brussels, on September 15th, 2011.
At the 2010 User Group meetings the groups talked about how the dictionary is used in everyday work – how this can be used as input to the developers of coding software and how we can develop
‘Best Practices’ based on these discussions. Best Practices have now been published as drafts and more are underway. At the User Group meeting in Brussels we will – among other things – develop these practices further with the coded data in mind; from the preparation of a clinical trial to the data collection and coding, data storage, analysis and interpretation.
Sign up at the User Group Portal to take part of what's new and ongoing in the WHO Drug Dictionaries.
Contact us at drugdictionary@umc-products.com to let us know if there are any speakers or topics that you would like to be present at the meeting.


Standardised Drug Groupings (SDGs) – Continues to Develop

In 2010 the first Standardised Drug Groupings were launched – additional classifications and lists that can be used in the preparation of Medication of Interest lists and for the analysis of coded data.
The work continues in 2011 – a new working group will put together new groupings, which will be prioritized and developed.
Please, let us know if you would like to suggest a new SDG or if you want to learn more about the SDGs. We welcome old as well as new members in the SDG Working Group.
Contact us at drugdictionary@umc-products.com if you want to participate – or if you want to know more about how the group is going to develop the new groupings.


Launch of the Japanese Cross Reference Tool

The UMC has together with ‘Ijoken’ - the maintenance organization Iyakuhinmey Data File (IDF) in Japan – created a Cross Reference Tool that will make it easy to find the WHO Drug Dictionary Enhanced code that corresponds to a selected code in the IDF dictionary (in Japanese). This will make it easy and possible to analyze IDF-coded data with the tools included in the WHO Drug Dictionary Enhanced. This tool is now being tested by few Japanese pharmaceutical companies and it will be launched in June, 2011.

EDQM News - June 2011

EDQM
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html

European Pharmacopoeia
Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia took place in Madrid on 9 to 10 May 2011. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

IMPORTANT: Rapid implementation of revised general chapter 5.2.8
The revised general chapter 5.2.8 Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products has been adopted following a fast-track procedure and is to be implemented on 1 July 2011. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

HealthCare – Blood Transfusion
2007 and 2008 Reports on the Collection, Testing and Use of Blood and Blood Components in Europe are now available to download: http://www.edqm.eu/en/Reports-70.html

Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html

Control of Medicines
European Network of Official Medicines Control Laboratories held its 16th Annual Meeting in Düsseldorf, Germany, from 23-27 May 2011.
More information: http://www.edqm.eu/en/News-and-General-Information-612.html

Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order.
NEW : ONLINE VERSION ALSO AVAILABLE. In order to be able to access the online version of this publication, you will need to register your print copy at : www.edqm.eu/register, using the EPID code attached at the back of the guide. Online registration gives users access to the guide in all the available languages.
More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html

Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Employment
Vacancy Notice N° e128/2011: Scientific Programme Officer (Grade A1/A2), Laboratory Department (Dlab) - Analytical Chemistry Division
Vacancy Notice N° e129/2011: Scientific Programme Officer (Grade A1/A2), Division Certification of Substances
Vacancy Notice N° e130/2011: Program Officer (Scientific) (Grade A1/A2), Division Certification of Substances
Closing date for all vacancies: 23 June 2011

Vacancy Notice N° e137/2011: Proofreader (Grade B3), European Pharmacopoeia Department (EPD) - Translation Unit

Closing date: 24 June 2011

Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html

Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html

Other interesting events supported by the EDQM:
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html

FDA MedWATCH

Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed

[UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm

Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication

[Posted 06/02/2011]

AUDIENCE: Consumers, Patients

ISSUE: FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.

BACKGROUND: Certain facilities, websites, and mobile units are promoting the use of thermography as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming that is a substitute for or superior to mammography. They also claim that thermography can detect pre-cancerous abnormalities and diagnose breast cancer long before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.

RECOMMENDATION: Woman should have regular mammograms according to screening guidelines or as recommended by a health care provider. Patients should follow a health care provider's recommendations for additional breast diagnostic procedure which could include thermography, clinical breast exam, breast ultrasound, MRI or biopsy.

Read the MedWatch safety alert, including links to the FDA Safety Communication, News Release, Consumer Update and other resources at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm
Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products


AUDIENCE: Pharmacy, Risk Manager

ISSUE: FDA and Aidapak Services notified healthcare professionals and hospital pharmacies of a nationwide recall of multiple repackaged drug products after learning of the potential cross contamination of non-penicillin drug products that were repackaged in the same facility. There is the potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products that could result from using these recalled products.

BACKGROUND: Please click on the link in the firm press release to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.

RECOMMENDATION: Hospitals, Emergency rooms, clinics and other healthcare facilities should stop distributing these products immediately and quarantine the products, and then contact Aidapak Services for return instructions.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257723.htm

FDA MedWatch

Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.


BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.


RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication and Questions and Answers, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm

What's New on the FDA Drugs Site

June 1, 2011

FDA Drug Safety Podcast for Healthcare Professionals: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
Manual of Policies and Procedures (MAPPs) Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups (PDF - 119KB)
National Drug Code Directory (updated)
New and Generic Drug Approvals

June 1, 2011

Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval
Donepezil Hydrochloride Tablets, Cipla Ltd., Approval
Donepezil Hydrochloride Tablets, Wockhardt Ltd., Approval
Donepezil Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
Donepezil Hydrochloride Tablets, Sandoz Inc., Approval
Donepezil Hydrochloride Tablets, Sun Pharmaceutical Industries Ltd., Approval
Donepezil Hydrochloride Tablets, Huahai US Inc., Approval
Donepezil Hydrochloride Tablets, Hikma Pharmaceuticals, Approval
Donepezil Hydrochloride Tablets, Actavis Pharma, Approval
Donepezil Hydrochloride Tablets, Torrent Pharmaceuticals Ltd., Approval
Donepezil Hydrochloride Tablets, Pliva Hrvatska, Approval
Donepezil Hydrochloride Tablets, Jubilant Life Sciences Ltd., Approval
Donepezil Hydrochloride Tablets, Teva Pharmaceuticals, Approval
Donepezil Hydrochloride Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Donepezil Hydrochloride Tablets, Aurobindo Pharma, Approval

ANMAT

http://www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/disp_3686-2011.pdf

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
PRODUCTOS MEDICINALES
Disposición 3686/2011
Establécense los Requisitos mínimos para solicitar la condición de venta
libre de una especialidad medicinal.

ANMAT TRAZABILIDAD

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
ESPECIALIDADES MEDICINALES
Disposición 3683/2011
Sistema de Trazabilidad de medicamentos que deberán implementar las
personas físicas o jurídicas que intervengan en la cadena de
comercialización, distribución y dispensación de especialidades
medicinales incluidas en el Registro de Especialidades Medicinales.

What's New on the FDA Drugs Site

May 23, 2011

Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Resolved Drug Shortages: BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
Drug Shortages: Resolved Drug Shortages: Renacidin Irrigation NDC 00327-0011-05
FDA approves Incivek (telaprevir)for hepatitic C
Table of Pharmacogenomic Biomarkers in Drug Labels (updated)

New and Generic Drug Approvals

May 23, 2011

Incivek (telaprevir) Tablets, Vertex Pharmaceuticals, Inc., Approval

FDA MedWATCH

Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results


AUDIENCE: Laboratory, Risk Manager

ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.

BACKGROUND: These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.

RECOMMENDATION: On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.

Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.

Healthcare professionals are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

MedWATCH

Pentrexyl Forte Natural: Recall - Misleading Packaging

AUDIENCE: Consumer, Pharmacy
ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be confused with an antibiotic. Pentrexyl Forte Natural is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.

BACKGROUND: The product is packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.

RECOMMENDATION: Consumers who have purchased the product can return it to the place where it was purchased.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

EDQM News - May 2011

EDQM
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html

European Pharmacopoeia
Decisions taken at the 139th Session of the PhEur Commission: http://www.edqm.eu/en/News-and-General-Information-43.html

Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes (Deadline: 30 June 2011)
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Policy document revised - Suspension or withdrawal of a CEP : http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin & impact of the revised EU Note for Guidance on TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html

HealthCare - Classification of Medicines as Regards their Supply
Evidence-based classification reviews 2007-2010 available : http://www.edqm.eu/en/page_1241.php

Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html

Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html

NEW: Pharmeuropa Bio & Scientific Notes 2011-1 (June 2011)
List of Contents now available. For more information on how to order : www.edqm.eu/store/
Instructions for Authors has been updated: http://www.edqm.eu/en/Pharmeuropa-Pharmeuropa-Bio-amp-Scientific-Notes-584.html

7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store

Technical Guides
Recommendations for the layout of monographs on substances of human and animal origin: http://www.edqm.eu/en/Technical-Guides-589.html
Employment
Vacancy Notice N° e105/2011: Fixed-term contract: Production/Distribution Operator (Grade C1/C2)
Reference Standards and Samples Division. Closing Date: 27 May 2011. More information: http://www.edqm.eu/en/Employment-1377.html

Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations : http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html

Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html

Other interesting events supported by the EDQM:
7-8 June 2011: 2011 PDA Europe Workshop on Advanced Therapy Medicinal Products in Collaboration with the Finnish Medicines Agency (Fimea)
Helsinki, Finland. More information: http://www.edqm.eu/en/Events-253.html

APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html

What's New on the FDA Drugs Site

May 20, 2011

FDA approves new HIV treatment
FDA approves Sutent (sunitinib) for rare type of pancreatic cancer
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
New and Generic Drug Approvals

May 20, 2011

Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision
Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision
Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Kwikpen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Pen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision
Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision
Victoza (liraglutide [rDNA origin]) Subcutaneous Solution, Novo Nordisk, Inc., Labeling Revision

SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition

AUDIENCE: Consumers, Pediatrics, Emergency medicine

ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.

BACKGROUND: FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.

The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

RECOMMENDATION: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.

Read the MedWatch safety alert, including links to the Press Release and product photos, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm



Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_20_2011_1800&cpp[type]=S

What is new in FDA

May 19, 2011

Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals

May 19, 2011

Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision

ANMAT: IMPLEMENTACIÓN DEL SISTEMA DE TRAZABILIDAD DE MEDICAMENTOS

16 de Mayo
En un acto realizado en el Salón Blanco de la Casa de Gobierno, la
Presidenta Cristina Fernández de Kirchner anunció ayer la implementación
del sistema de trazabilidad de medicamentos, con el objeto de asegurar el
control de dichos productos y así contribuir a erradicar la circulación de
aquellos que sean ilegítimos.
El sistema de trazabilidad, creado mediante la Resolución Nº 435/2011
del Ministerio de Salud de la Nación, consistirá en la identificación individual
y unívoca de cada unidad a ser comercializada, por parte de todas las
personas y empresas que intervengan en la cadena de comercialización,
distribución y dispensación de especialidades medicinales. Ello permitirá
efectuar su seguimiento a través de toda la cadena de distribución
(laboratorios, distribuidoras, operadores logísticos, droguerías, farmacias,
establecimientos asistenciales y pacientes).
Además, mediante la implementación de la trazabilidad, que será llevada
a cabo por la ANMAT, los productos brindarán toda la información
suministrada actualmente por el sistema de troqueles, a fin de asegurar su
reemplazo. Dicha información será incorporada a una base informática, en
la que deberán quedar asentados los datos identificatorios de cada unidad y
todos los pasos relacionados con el proceso de su distribución.
Por último, la norma prescribe que toda la documentación comercial que
emitan los laboratorios, distribuidoras, operadores logísticos y droguerías,
en sus operaciones de provisión, deberá incluir el número de lote y la fecha
de vencimiento de las especialidades medicinales alcanzadas por el sistema
de trazabilidad.

What's New on the FDA Drugs Site

May 16, 2011

CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD. Meeting information
Drug Firm Annual Registration Status (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 65KB)
FDA-Industry Meeting Minutes, January 31, 2011 (PDF - 64KB)
New and Generic Drug Approvals

May 16, 2011

Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
Irinotecan Hydrochloride Injection, Bioniche Pharma USA LLC., Approval
Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck Sharp and Dohme Corp., Labeling Revision
Levocetirizine Dihydrochloride Oral Solution, Synthon Pharmaceuticals, Inc., Tentative Approval
Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supplement
Sodium Polystyrene Sulfonate Suspension, Paddock Laboratories, Inc., Approval
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision

What is new in FDA

May 13, 2011

Drug Shortages: Current Drug Shortages: Thiotepa for Injection (updated)
FDA Approves Victrelis (boceprevir) to Treat Certain Adults with Chronic Hepatitis C
Orange Book: Additions/Deletions for Prescription and OTC Drug Product Lists
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Search
Orange Book: Cumulative Supplement (PDF - 1020KB)
Orange Book: Query Data Files
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals

May 13, 2011

Abacavir Sulfate and Lamivudine Oral Suspension Tablets, Cipla, Ltd., Tentative Approval
CeeNU (lomustine) Capsules, Bristol Myers Squibb Co., Labeling Revision
Cutivate (fluticasone propionate) Lotion, Nycomed U.S., Inc., Labeling Revision
Iosat (potassium iodide) Tablets, Anbex, Inc., Chemistry New Strength
Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
Nitrofurantoin Oral Suspension, Amneal Pharmaceuticals, Approval
Octreotide Acetate (Preservative Free) Injection, Wockhardt, Ltd., Approval
Oleptro (trazodone hydrochloride) Extended-Release Tablets, Angelini Labopharm Limited Partnership, Labeling Revision
Orsythia (levonorgestrel and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval
Vibramycin (doxycycline) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline calcium) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline hyclate) Capsules, Pfizer Global Research and Development, Labeling Revision
Vibra-Tabs (doxycycline hyclate) Tablets, Pfizer Global Research and Development, Labeling Revision
Victrelis (boceprevir) Capsules, Schering Corp, Approval

What's New on the FDA Drugs Site

May 12, 2011

Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
FDA Issues Warning Letters to Teva Pharmaceutical Industries and Moehs Cantabra for CGMP violations
Postmarketing Drug Safety Evaluations (updated)
New and Generic Drug Approvals

May 12, 2011

Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Sandoz, Inc., Tentative Approval
Bromfenac Sodium Ophthalmic Solution, Coastal Pharmaceuticals, Approval
Dexamethasone Elixir, Vintage Pharmaceuticals, Approval
Lexiva (fosamprenavir calcium) Tablets, ViiV Healthcare Company, Labeling Revision
Lexiva (fosamprenavir calcium) Oral Suspension, ViiV Healthcare Company, Labeling Revision
Ranitidine Hydrochloride Tablets, Perrigo R&D Company, Approval
Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Venlafaxine Hydrochloride Extended-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval
Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision

REQUISITOS PARA PRODUCTOS PROVENIENTES DEL JAPÓN

Atento los acontecimientos que son de dominio público, la ANMAT, en
cumplimiento de sus funciones de fiscalización destinadas a la protección y
promoción de la salud, y con la voluntad de cooperar con la nación del
Japón, ha determinado como necesaria la siguiente normativa para la
importación de productos de origen japonés que requieran de su
habilitación:
1. Para productos médicos (dispositivos), odontológicos, medicamentos o
materias primas relacionadas con éstos, se deberá aportar:
• Una declaración jurada por parte del importador, aclarando el
origen y fecha de elaboración de la mercadería a ingresar y, si
correspondiera, el lugar y período de almacenamiento.
Nota: la ANMAT se reserva el derecho de realizar un muestreo al azar sobre
el material ingresado, con el objetivo de solicitar al importador la
presentación de un informe emitido por la Autoridad Regulatoria Nuclear
(ARN) en el que se consigne el nivel de reactividad existente en el producto.
La gestión ante la ARN queda a cargo del importador.
2. Para alimentos y otros productos de competencia del Instituto Nacional
de Alimentos (INAL):
• Completar el formulario de declaración jurada
Nota: la ANMAT se reserva el derecho de realizar un muestreo al azar sobre
el material ingresado, con el objetivo de solicitar al importador la
presentación de un informe emitido por la Autoridad Regulatoria Nuclear
(ARN) en el que se consigne el nivel de reactividad existente en el producto.
La gestión ante la ARN queda a cargo del importador.

NEW AND EXCITING DIA 2011

DIA 2011 reflects our vision to be a global forum for innovation to facilitate better health care worldwide. DIA 2011, unlike any other event of its kind, addresses all the tough issues, including multinational clinical research, facing professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. It’s a meeting you can’t afford to miss! Go to www.diahome.org/registerDIA2011 for up-to-the-minute information.

TOPICS IN CLINICAL RESEARCH

DIA 2011 is moving in a new direction in an effort to streamline the program and focus on the hottest topics. DIA 2011 features new scope areas for DIA, including coverage of topics related to clinical research/trials:

Regulatory Roundtable on Biosimilar Policies
Defining Quality in Clinical Trials
Quality Risk Management in Product Development: The Assessment, Identification, and Control of Potential Risk
Drug Product Liability in the United States and the European Union
Recent Advancement of Biosimilars in Asian Pacific Region

What's New on the FDA Drugs Site

May 9, 2011

Guidance for Industry:
New/Revised Withdrawn List for 2011 (PDF - 55KB)
New/Revised/Withdrawn List for 2010 (PDF - 120KB)
Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
FDA/DDMAC issue letter to ChemGenex Pharmaceuticals for Omapro (PDF - 87KB)
FDA/DDMAC issue letter to Warner Chilcott (US) LLC for Atelvia (PDF - 63KB)

ANMAT RECUERDA: MEDICAMENTOS CON ERGOTAMINA DEBEN CONSUMIRSE BAJO PRESCRIPCIÓN MÉDICA

Teniendo en cuenta que se han recibido algunos reportes de efectos adversos graves relacionados con el principio activo ergotamina, la ANMAT recuerda a la población y a los profesionales de la salud que los medicamentos que contienen dicha droga se encuentran autorizados como de venta bajo receta, por lo que su administración debe producirse bajo exclusiva prescripción médica.
En efecto, entre los años 2007 y 2010, el Sistema Nacional de Farmacovigilancia recibió ocho notificaciones de reacciones adversas ocasionadas por especialidades medicinales que contienen
ergotamina, un principio activo indicado para el tratamiento de dolores de cabeza y migrañas. En varios casos, los pacientes debieron ser hospitalizados.
Algunos de los reportes recepcionados daban cuenta de la interacción de la droga mencionada con el principio activo ritonavir, el cual se encuentra indicado para el tratamiento del HIV. En tal sentido, cabe destacar que el consumo crónico de ergotamina, o su administración junto con antirretrovirales inhibidores de las enzimas del citocromo P450, como el ritonavir, puede provocar una reacción adversa grave denominada ergotismo. Ésta se caracteriza por una vasocontricción periférica cuyos síntomas son ausencia de pulso, frialdad, parestesias
y dolor intenso de los miembros inferiores y/o de las manos.
Por todo lo expuesto, se desaconseja el uso de la ergotamina en forma prolongada o asociado a antirretrovirales.

SEMINARIO INTERNACIONAL DE PUBLICIDAD DE MEDICAMENTOS Y ALIMENTOS

Entre los días 5 y 6 de mayo, con la participación de especialistas de autoridades reguladoras sanitarias de diversos países, se realizará el "Seminario Internacional de Publicidad y Promoción de Medicamentos y Alimentos: el contenido del mensaje". El evento, organizado por la ANMAT, el Ministerio de Salud de la Nación, la Organización Panamericana de la Salud (OPS) y la Asociación Argentina de Farmacia y Bioquímica Industrial (SAFYBI) se realizará en el NH City & Tower, ubicado en Bolívar 160 de la ciudad de Buenos Aires.
Durante el seminario se llevarán a cabo varias mesas de presentación a cargo de los especialistas de las agencias reguladoras, en las que se discutirán los siguientes temas:
- “El contenido de los mensajes en la publicidad de medicamentos de venta libre”;
- “Escenario de la promoción de los medicamentos bajo receta y su uso racional”;
- “La publicidad de alimentos con ‘propiedades saludables’ y su impacto en los hábitos de consumo”.
- “La publicidad de alimentos en general y suplementos dietarios, y su impacto en los hábitos de consumo”.
El encuentro se motiva en la influencia creciente de la publicidad y promoción de productos para la salud en los hábitos de consumo de la población, y la consiguiente necesidad de intercambiar conocimientos en la materia por parte de las autoridades sanitarias, a fin de proceder a su efectiva regulación.

What's New on the FDA Drugs Site

May 5, 2011

Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
Special Feature: FDA Encourages Pediatric Information on Drug Labeling
Guidance for Industry: Submission of Summary Bioequivalence Data for ANDAs (PDF - 138 KB)
Postmarket Requirements and Commitments
Download
Search
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011
FDA-Industry Meeting Minutes, February 10, 2011
FDA-Industry Meeting Minutes, February 4, 2011

What is new in FDA

May 2, 2011

FDA/DDMAC Issue Warning Letter to Three Rivers Pharmaceuticals for Infergen
Acronyms and Abbreviations File Download (updated)
Drug Shortages: Current Drug Shortages: Fentanyl Transdermal System (updated)
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium phosphate injection (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
New and Generic Drug Approvals

May 02, 2011

AndroGel (testosterone) Gel, Abbott Products, Inc., Approval
Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Valeant Pharmaceuticals, Labeling Revision
Celecoxib Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
Donepezil Hydrochloride Tablets, Matrix Laboratories Limited, Tentative Approval
Fusilev (levoleucovorin calcium) I.V. Powder, Spectrum Pharmaceuticals, Inc., Efficacy Supplement
Gemcitabine Injection, Bedford Laboratories, Tentative Approval
Kytril (granisetron hydrochloride) Injection, Hoffmann-La Roche Inc., Efficacy Supplement
Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche Inc., Supplement
NegGram (nalidixic acid) Caplets, Sanofi-aventis U.S. Inc., Labeling Revision
Nexium I.V. (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Efficacy Supplement

New and Generic Drug Approvals April 28, 2011

Drugs@FDA Download File (updated)
Drug Firm Annual Registration Status (updated)
FDA approves Zytiga for late-stage prostate cancer
Generic Drug User Fee; Public Meeting; Request for Comments; May 10, 2011, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103, and 4105, Silver Spring, MD 20993-0002. Meeting information
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Natural Disaster Response (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Stakeholder Meeting Minutes, March 18, 2011 (PDF - 71KB)
FDA-Stakeholder Meeting Minutes, February 28, 2011 (PDF - 76KB)
FDA-Industry Meeting Minutes, March 31, 2011 (PDF - 69KB)
FDA-Industry Meeting Minutes, March 25, 2011 (PDF - 62KB)
FDA-Industry Meeting Minutes, March 15, 2011 (PDF - 62KB)
FDA-Industry Meeting Minutes, March 10, 2011 (PDF - 63KB)
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 70KB)
FDA-Industry Meeting Minutes, February 15, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 80KB)




Pediatric Advil (ibuprofen) Oral Suspension, Pfizer Consumer Healthcare, Labeling Revision
Advil (ibuprofen) Tablets, Pfizer Consumer Healthcare, Labeling Revision
Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets, Reddy's Laboratories Ltd., Approval
Duexis (ibuprofen and famotidine) Tablets, Horizon Pharma, Inc., Approval
Lyrica (pregabalin) Capsules, Pfizer, Inc., Labeling Revision
Lyrica (pregabalin) Oral Solution, Pfizer, Inc., Labeling Revision
Naratriptan Tablets, Apotex Corp., Approval
Premarin (conjugated estrogens) Vaginal Cream, Pfizer Inc., Labeling Revision
Savella (milnacipran hydrochloride) Tablets, Forest Laboratories, Inc., Supplement
Zytiga (abiraterone acetate) Tablets, Centocor Ortho Biotech, Inc, Approval

PROGRAMA DE FISCALIZACIÓN DE PUBLICIDAD

Con el objeto de optimizar las funciones de vigilancia sanitaria de esta
Administración Nacional, y luego de la importante experiencia que ha reunido la
Comisión de Fiscalización y Control de Publicidad, la ANMAT acaba de poner en
marcha el Programa de Monitoreo y Fiscalización de Publicidad y Promoción
de Productos Sujetos a Vigilancia Sanitaria.
La función principal del programa, creado mediante la Disposición Nº 2845/11,
será el monitoreo y evaluación de la publicidad emitida en medios masivos de
comunicación y medios especializados, respecto a los productos sujetos a vigilancia
sanitaria (medicamentos, alimentos, productos médicos, cosméticos, productos de
uso doméstico).
Asimismo, el programa buscará fomentar la integración e interacción con otros
organismos gubernamentales (provinciales y nacionales), sector regulado, ONG’s e
instituciones educativas, para la colaboración de las actividades de monitoreo de
piezas publicitarias.
Por otra parte, este canal reforzará el vínculo con los consumidores, quienes podrán
acceder a toda la información regulatoria actualizada y de las actividades llevadas a
cabo por el Programa.
La coordinación del Programa estará a cargo del Lic. Sebastián Duarte.

EDQM News - April 2011

EDQM
A symposium on combating counterfeit and other illegal medicines, specifically targeted for Official Medicines Control Laboratories (OMCLs), took place at the EDQM in Strasbourg. More information: http://www.edqm.eu/en/News-and-General-Information-612.html

European PharmacopoeiaDuring its 139th session, the European Pharmacopoeia Commission adopted seven new individual monographs, two new general monographs and a new analytical method. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

Reference Standards
The EDQM has completed the United Nations Economic Commission for Europe (UNECE) GHS hazard classification as at the EDQM supplies as reference standards. All stakeholders are invited to review and, if necessary, comment on the proposed GHS Classifications. Consultation ends 30th April 2011. More information: http://www.edqm.eu/en/Quality-Safety-amp-Environment-76.html

Control of Medicines
Human Biologicals Contact List (Annex III) for the Network of Competent Authorities has been updated : http://www.edqm.eu/en/Human-Biologicals-OCABR-611.html
Veterinary Batch Release Contact List (Annex IV) has been updated: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html

Pharmeuropa 23.2
www.edqm.eu/store/


7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store

7th Edition European Pharmacopoeia - Supplement 7.3
List of Contents now available to download (under the Downloads section):
http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html

NEW: Symposium on “Alternatives to Animal Testing”, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html

Quality of Medicines in a Globalised World of Medicines - Conference Proceedings now available to download: http://www.edqm.eu/en/Proceedings-of-International-Conferences-83.html

Other interesting events supported by the EDQM:
APIB Event "Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues", 14-17 June 2011, Madrid, Spain.
Deadline for Early Registration: 16th May. More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html

Novedades FDA

What's New on the FDA Drugs Site
April 25, 2011
Approved Drug Products List - Orange Book
Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Phenylephrine HCl Injection



New and Generic Drug Approvals
April 25, 2011
Children’s Cetirizine Hydrochloride (cetirizine hydrochloride) Oral Solution, Silarx Pharmaceuticals, Inc., Approval
Rizatriptan Benzoate Tablets, Cipla Ltd., Tentative Approval
Sorilux (calcipotriene) Foam, Stiefel Laboratories, Inc., Labeling Revision
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision

FDA issues complete response letter for patch version of Eisai's Aricept (Ref: MarketWatch, Business Wire, Bloomberg) April 25th, 2011 By: Lianne Dane

Eisai announced Monday that the FDA issued a complete response letter regarding the application for a weekly transdermal version of Aricept (donepezil) for the treatment of mild, moderate and severe stages of Alzheimer’s disease. In its decision, the agency questioned usage of the patch.

The Japanese drugmaker said it will work with patch developer Teikoku Seiyaku to assess the agency's correspondence and determine its next steps. However, Eisai spokesman Takeshi Shimizu indicated that the company will not comment on whether further discussions with the FDA will delay sales of the patch, which had been projected to reach the market as early as June.

Eisai holds the marketing rights to the product in the US and if approved, will co-promote this dosing version with Pfizer. The company is looking to launch new formulations of Aricept in order to offset sales lost following the entry of generic versions of the compound in the US market.

ANMAT RECUERDA: MEDICAMENTOS CON ERGOTAMINA DEBEN
CONSUMIRSE BAJO PRESCRIPCIÓN MÉDICA
Teniendo en cuenta que se han recibido algunos reportes de efectos
adversos graves relacionados con el principio activo ergotamina, la
ANMAT recuerda a la población y a los profesionales de la salud que
los medicamentos que contienen dicha droga se encuentran
autorizados como de venta bajo receta, por lo que su
administración debe producirse bajo exclusiva prescripción
médica.
En efecto, entre los años 2007 y 2010, el Sistema Nacional de
Farmacovigilancia recibió ocho notificaciones de reacciones adversas
ocasionadas por especialidades medicinales que contienen
ergotamina, un principio activo indicado para el tratamiento de
dolores de cabeza y migrañas. En varios casos, los pacientes debieron
ser hospitalizados.
Algunos de los reportes recepcionados daban cuenta de la interacción
de la droga mencionada con el principio activo ritonavir, el cual se
encuentra indicado para el tratamiento del HIV. En tal sentido, cabe
destacar que el consumo crónico de ergotamina, o su administración
junto con antirretrovirales inhibidores de las enzimas del citocromo
P450, como el ritonavir, puede provocar una reacción adversa grave
denominada ergotismo. Ésta se caracteriza por una vasocontricción
periférica cuyos síntomas son ausencia de pulso, frialdad, parestesias
y dolor intenso de los miembros inferiores y/o de las manos.
Por todo lo expuesto, se desaconseja el uso de la ergotamina en
forma prolongada o asociado a antirretrovirales.

ANMAT ADOPTA FIRMA DIGITAL
En el marco del “Programa de Despapelización Segura” que se encuentra
implementando esta Administración Nacional, la ANMAT acaba de adoptar,
mediante la Disposición Nº 2577/11, la firma digital.
Esta herramienta, que se encuentra contemplada en la ley 25.506, apunta a
establecer una infraestructura que ofrezca autenticación y garantía de integridad
para los documentos digitales o electrónicos, y constituya la base tecnológica para
otorgarles validez jurídica. Ello facilitará la realización de los trámites
administrativos, y disminuirá los obstáculos derivados de las barreras geográficas.
Teniendo en cuenta el gran número y la variedad de trámites y actuaciones
administrativas que se gestionan ante este organismo, y a los diversos actores que
intervienen en ellas, la instrumentación de la medida será progresiva. En una
primera etapa, el proyecto de digitalización se focalizará preferentemente en las
tramitaciones en las cuales esta Administración Nacional ya ha ido incorporando
herramientas basadas en las Tecnologías de la Información y las Comunicaciones
(TICs), para luego ir ampliándose, en forma gradual, a las restantes

Farmacopeas de los distintos países, publicación de la OMS http://www.who.int/medicines/publications/pharmacopoeia/WHOPSMQSM2006_2_IndexPharmacopoeiasUpdated.pdf Consultado 24-4-11