What's New on the FDA Drugs Site
February 8, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs
- Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (PDF - 214KB)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
February 7, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aleve | naproxen sodium | Tablet; Oral | Bayer | Labeling Revision |
| Calcium Acetate | calcium acetate | Capsule; Oral | Invagen Pharms | Approval |
| Isopto Carpine | pilocarpine hydrochloride | Solution; Ophthalmic | Alcon Res | Manufacturing Change or Addition |
| Janumet | metformin hydrochloride; sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Januvia | sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Monistat 3 | miconazole nitrate | Suppository; Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Novolin R | insulin recombinant human | Injectable; Injection | Novo Nordisk Inc | Labeling Revision |
| Saizen | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Sandimmune | cyclosporine | Injectable; Injection | Novartis | Manufacturing Change or Addition |
| Tamiflu | oseltamivir phosphate | For Suspension; Oral | Roche | Manufacturing Change or Addition |
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