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
jueves, 26 de mayo de 2011
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
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
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
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
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
lunes, 23 de mayo de 2011
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
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
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
viernes, 20 de mayo de 2011
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.
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
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
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
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
miércoles, 11 de mayo de 2011
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.
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
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
martes, 10 de mayo de 2011
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)
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.
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.
viernes, 6 de mayo de 2011
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.
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
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
miércoles, 4 de mayo de 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
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
Suscribirse a:
Entradas (Atom)