What's New on the FDA Drugs Site
August 29, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
- MedWatch Safety Alert: Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
- MedWatch Safety Alert: JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
- National Drug Code Directory
New and Generic Drug Approvals
August 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aciphex Sprinkle | rabeprazole sodium | Capsule, Delayed Release; Oral | Eisai Inc | Manufacturing Change or Addition |
| Aerospan Hfa | flunisolide | Aerosol, Metered; Inhalation | Acton Pharms | Efficacy Supplement with Clinical Data to Support |
| Dexmethylphenidate Hydrochloride | dexmethylphenidate hydrochloride | Capsule, Extended Release; Oral | Mylan Pharms Inc | Approval |
| Duexis | famotidine; ibuprofen | Tablet; Oral | Horizon Pharma | Manufacturing Change or Addition |
| Gatifloxacin | gatifloxacin | Solution/Drops; Ophthalmic | Lupin Ltd | Approval |
| Lexiva | fosamprenavir calcium | Tablet; Oral | Viiv Hlthcare | Manufacturing Change or Addition |
| Lialda | mesalamine | Tablet, Delayed Release; Oral | Shire | Labeling Revision |
| Sirturo | bedaquiline fumarate | Tablet; Oral | Janssen Therap | Labeling Revision |
| Treanda | bendamustine hydrochloride | Powder; Iv (Infusion) | Cephalon | Labeling Revision |
| Zebeta | bisoprolol fumarate | Tablet; Oral | Teva Womens | Manufacturing Change or Addition |
| Zioptan | tafluprost | Solution/Drops; Ophthalmic | Merck Sharp Dohme | Manufacturing Change or Addition |
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