What's New on the FDA Drugs Site
March 1, 2013
- Attention Prescribers: FDA seeks your help in curtailing the U.S. opioid epidemic
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Spanish FDA Drug Safety Communication: Sensipar: FDA suspende pruebas clínicas de Sensipar (hidrocloruro de cinacalcet) tras reporte de fallecimiento
New and Generic Drug Approvals
February 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify Maintena | aripiprazole | Injectable; Injection | Otsuka Pharm | Approval |
| Avapro | irbesartan | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Claritin | loratadine | Syrup; Oral | Schering Plough | Manufacturing Change or Addition |
| Claritin Hives Relief | loratadine | Syrup; Oral | Schering Plough | Manufacturing Change or Addition |
| Creon | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release; Oral | Abbvie | Manufacturing Change or Addition |
| Desmopressin Acetate | desmopressin acetate | Tablet; Oral | Ferring | Manufacturing Change or Addition |
| Hexalen | altretamine | Capsule; Oral | Eisai Inc | Manufacturing Change or Addition |
| Levetiracetam | levetiracetam | Solution; Oral | Hetero Drugs Ltd | Approval |
| Lumigan | bimatoprost | Solution/Drops; Ophthalmic | Allergan | Manufacturing Change or Addition |
| Lyrica | pregabalin | Solution; Oral | Pf Prism | Efficacy Supplement with Clinical Data to Support |
| Neoprofen | ibuprofen lysine | Injectable; Intravenous | Lundbeck Llc | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Sildenafil Citrate | sildenafil citrate | Tablet; Oral | Amneal Pharms | Tentative Approval |
| Sildenafil Citrate | sildenafil citrate | Tablet; Oral | Amneal Pharms | Approval |
| Valsartan | valsartan | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Xalkori | crizotinib | Capsule; Oral | Pfizer | Labeling Revision |
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