What's New on the FDA Drugs Site
February 20, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy
- Manual of Policies and Procedures (CDER-MAPP) 5021.1 (PDF - 159KB) Naming of Drug Products Containing Salt Drug Substances
- National Drug Code Directory (updated)
- Orange Book (updated)
- Paragraph IV Patent Certifications (updated)
- Warning Letters 2013 (updated)
New and Generic Drug Approvals
February 19, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amyvid | florbetapir f-18 | Solution; Intravenous | Avid Radiopharms Inc | Labeling Revision |
| Amyvid | florbetapir f-18 | Solution; Intravenous | Avid Radiopharms Inc | Manufacturing Change or Addition |
| Chantix | varenicline tartrate | Tablet; Oral | Pfizer Inc | Efficacy Supplement with Clinical Data to Support |
| Ellence | epirubicin hydrochloride | Injectable; Injection | Pfizer Inc | 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 |
| Lorazepam | lorazepam | Concentrate; Oral | Lupin Ltd | Approval |
| Miacalcin | calcitonin salmon | Injectable; Injection | Novartis | Manufacturing Change or Addition |
| Zithromax | azithromycin | For Suspension; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | For Suspension; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Injectable; Injection | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
| Zmax | azithromycin | For Suspension, Extended Release; Oral | Pfizer Global | Labeling Revision |
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