What's New on the FDA Drugs Site
February 7, 2013
- Pharmacy Compounding (updated)
- Letter to PharmMEDium (2/5/2013)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (PDF - 249KB)
- FDA offers new guidance on developing drugs for Alzheimer’s disease
- National Drug Code Directory (updated)
- Pediatric Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
New and Generic Drug Approvals
February 6, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Canasa | mesalamine | Suppository; Rectal | Aptalis Pharma Us | Labeling Revision |
| Cetirizine Hydrochloride Allergy | cetirizine hydrochloride | Capsule; Oral | Banner Pharmacaps | Labeling Revision |
| Cetirizine Hydrochloride Hives Relief | cetirizine hydrochloride | Capsule; Oral | Banner Pharmacaps | Labeling Revision |
| Copegus | ribavirin | Tablet; Oral | Roche | Labeling Revision |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff Pen | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Intermezzo | zolpidem tartrate | Tablet; Sublingual | Purdue Pharma | Manufacturing Change or Addition |
| Lucentis | ranibizumab | Injectable; Injection | Genentech | Efficacy Supplement with Clinical Data to Support |
| Monistat 1 Combination Pack | miconazole nitrate | Cream, Suppository; Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Monistat Dual- Pak | miconazole nitrate | Cream, Insert; Topical, Vaginal | Personal Prods | Manufacturing Change or Addition |
| Monistat-3 Combination Pack | miconazole nitrate | Cream, Suppository; Topical, Vaginal | Insight Pharms | Manufacturing Change or Addition |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Macleods Pharms Ltd | Approval |
| Rebetol | ribavirin | Capsule; Oral | Merck Sharp Dohme | Labeling Revision |
| Rebetol | ribavirin | Solution; Oral | Schering | Labeling Revision |
| Valsartan | valsartan | Tablet; Oral | Dr Reddys Labs Ltd | Tentative Approval |
| Versacloz | clozapine | Suspension; Oral | Douglas Pharms | Supplement |
| Zylet | loteprednol etabonate; tobramycin | Suspension/Drops; Ophthalmic | Bausch and Lomb | Efficacy Supplement with Clinical Data to Support |
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