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