What's New on the FDA Drugs Site
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
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