What's New on the FDA Drugs Site
August 5, 2013
- FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
August 2, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Buphenyl | sodium phenylbutyrate | Tablet; Oral | Medicis | Manufacturing Change or Addition |
| Cancidas | caspofungin acetate | Injectable; Iv (Infusion) | Merck | Labeling Revision |
| Candesartan Cilexetil | candesartan cilexetil | Tablet; Oral | Apotex Inc | Tentative Approval |
| Forteo | teriparatide recombinant human | Injectable; Subcutaneous | Lilly | Manufacturing Change or Addition |
| Gabapentin | gabapentin | Capsule; Oral | Taro Pharms North | Approval |
| Levitra | vardenafil hydrochloride | Tablet; Oral | Bayer Hlthcare | Efficacy Supplement with Clinical Data to Support |
| Mucinex D | guaifenesin; pseudoephedrine hydrochloride | Tablet, Extended Release; Oral | Reckitt Benckiser | Manufacturing Change or Addition |
| Staxyn | vardenafil hydrochloride | Tablet, Orally Disintegrating; Oral | Bayer Hlthcare | Efficacy Supplement with Clinical Data to Support |
| Valstar Preservative Free | valrubicin | Solution; Intravesical | Endo Pharm | Efficacy Supplement with Clinical Data to Support |
| Velcade | bortezomib | Injectable; Intravenous, Subcutaneous | Millennium Pharms | Manufacturing Change or Addition |
| Xenazine | tetrabenazine | Tablet; Oral | Valeant Bermuda | Labeling Revision |
| Ziana | clindamycin phosphate; tretinoin | Gel; Topical | Medicis | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable; Injection | Acs Dobfar Info Sa | Approval |
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