What's New on the FDA Drugs Site
February 3, 2015
- CDER Conversation: FDA's drug shortages prevention strategies
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- Zinc Injection (Updated - Resolved)
- Public Notification: Yanhee Slim contains hidden drug ingredient
- National Drug Code Directory
New and Generic Drug Approvals
February 2, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Miacalcin | calcitonin salmon | Injectable;Injection | Sebela Ireland Ltd | Labeling Revision |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution;Ophthalmic | Watson Labs | Tentative Approval |
| Vytorin | ezetimibe; simvastatin | Tablet;Oral | Msd Intl | Labeling Revision |
| Zocor | simvastatin | Tablet;Oral | Merck | Labeling Revision |
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Wednesday, February 4, 2015
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