What's New on the FDA Drugs Site
April 1, 2013
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Electronic Drug Registration and Listing Instructions (updated)
- Guidance for Industry: SUPAC: Manufacturing Equipment Addendum (PDF - 168KB)
- MedWatch Safety Alert - Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates
- National Drug Code Directory (updated)
- Nicotine-Containing Products
New and Generic Drug Approvals
March 29, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Brilinta | ticagrelor | Tablet; Oral | Astrazeneca Lp | Labeling Revision |
| Foradil | formoterol fumarate | Powder; Inhalation | Novartis | Labeling Revision |
| Invokana | canagliflozin | Tablet; Oral | Janssen Res and Dev | Approval |
| Salonpas | menthol; methyl salicylate | Patch; Topical | Hisamitsu Pharm Co | Efficacy Supplement with Clinical Data to Support |
| Tramadol Hydrochloride | tramadol hydrochloride | Tablet; Oral | Cspc Ouyi Pharma Co Ltd | Approval |
| Venofer | iron sucrose | Injectable; Intravenous | Luitpold | Manufacturing Change or Addition |
| Vesicare | solifenacin succinate | Tablet; Oral | Astellas | Labeling Revision |
| Voraxaze | glucarpidase | Injectable; Injection | Btg International Inc | Labeling Revision |
| Zoledronic Acid | zoledronic acid | Injectable; Injection | Dr Reddys Labs Ltd | Approval |
| Zoledronic Acid | zoledronic acid | Injectable; Injection | Emcure Pharms Ltd | Approval |
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