What's New on the FDA Drugs Site
January 12, 2012
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 380KB)
- Drug Shortages: Amphetamine Mixed Salts Immediate-Release Tablets (updated)
- Drug Shortages: Current Drug Shortages: Dextroamphetamine Tablets
- Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
- FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-82
- MedWatch Safety Alert: Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles
- CDER Data Standards Program (updated)
New and Generic Drug Approvals
January 11, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Docetaxel | docetaxel | Injectable; Injection | Apotex Inc | Approval |
| Irbesartan | irbesartan | Tablet; Oral | Apotex Inc | Tentative Approval |
| Synarel | nafarelin acetate | Spray, Metered; Nasal | Gd Searle Llc | Labeling Revision |
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