What's New on the FDA Drugs Site
February 29, 2012
- Drug Firm Annual Registration Status Download File (ZIP - 386KB)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Drug Shortages: Current Drug Shortages: Metoclopramide Injection (updated)
- Drugs@FDA Download File (updated)
February 28, 2012
- Drug Firm Annual Registration Status Download File (ZIP - 386KB)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Cosyntropin Injection (updated)
- FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs
- Guidance for Industry: Size of Beads in Drug Products Labeled for Sprinkle (PDF - 40KB)
New and Generic Drug Approvals
February 28, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Crestor | rosuvastatin calcium | Tablet; Oral | Ipr | Labeling Revision |
| Diovan | valsartan | Tablet; Oral | Novartis | Labeling Revision |
| Lescol | fluvastatin sodium | Capsule; Oral | Novartis | Labeling Revision |
| Lescol Xl | fluvastatin sodium | Tablet, Extended Release; Oral | Novartis | Labeling Revision |
| Levetiracetam | levetiracetam | Solution; Oral | Hi-Tech Pharmacal | Approval |
| Lipitor | atorvastatin calcium | Tablet; Oral | Pfizer | Labeling Revision |
| Livalo | pitavastatin calcium | Tablet; Oral | Kowa Co | Labeling Revision |
| Mevacor | lovastatin | Tablet; Oral | Merck | Labeling Revision |
| Olanzapine | olanzapine | Tablet, Orally Disintegrating; Oral | Sun Pharm Inds | Approval |
| Olanzapine | olanzapine | Tablet; Oral | Torrent Pharms Ltd | Tentative Approval |
| Pravachol | pravastatin sodium | Tablet; Oral | Bristol Myers Squibb | Labeling Revision |
| Simcor | niacin; simvastatin | Tablet, Extended Release; Oral | Abbott | Labeling Revision |
| Vytorin | ezetimibe; simvastatin | Tablet; Oral | Msd Intl | Labeling Revision |
| Zocor | simvastatin | Tablet; Oral | Merck | Labeling Revision |
February 27, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Avonex | interferon beta-1a | Vial | Biogen | Efficacy Supplement with Clinical Data to Support |
| Caspofungin Acetate | caspofungin acetate | Injectable; Injection | Sandoz Inc | Tentative Approval |
| Differin | adapalene | Gel; Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Cipla Limited | Tentative Approval |
| Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Januvia | sitagliptin phosphate | Tablet; Oral | Merck Co Inc | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.1% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Methotrexate Preservative Free | methotrexate | Injectable; Injection | Pharmachemie Bv | Approval |
| Novolin R | insulin recombinant human | Injectable; Injection | Novo Nordisk Inc | Labeling Revision |
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