What's New on the FDA Drugs Site
May 24, 2013
- Current Drug Shortages Index (updated)
- Draft Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 86KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee
- Guidance for Industry: Q4B: Annex 13 Bulk Density and Tapped Density of Powders General Chapter. (PDF version - 94KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- National Drug Code Directory
New and Generic Drug Approvals
May 23, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Condylox | podofilox | Solution; Topical | Watson Pharms | Manufacturing Change or Addition |
| Nicorette | nicotine polacrilex | Troche/Lozenge; Oral | Glaxosmithkline Cons | Labeling Revision |
| Tygacil | tigecycline | Injectable; Iv (Infusion) | Wyeth Pharms Inc | Labeling Revision |
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