What's New on the FDA Drugs Site
August 11, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
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FDA Drug Shortages: New and Updated
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Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
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- National Drug Code Directory
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Pediatric Written Requests (updated)
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Public Notification: Herbal Vigor Quick Fix Contains Hidden Drug Ingredient
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Public Notification: Arize Contains Hidden Drug Ingredient
New and Generic Drug Approvals
August 8, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Capecitabine | capecitabine | Tablet;Oral | Mylan Pharms Inc | Approval |
| Farxiga | dapagliflozin | Tablet;Oral | Astrazeneca Ab | Labeling Revision |
| Invokamet | canagliflozin and metformin hydrochloride | Tablet; Oral | Janssen Pharms | Approval |
| Juxtapid | lomitapide mesylate | Capsule;Oral | Aegerion | Labeling Revision |
| Silenor | doxepin hydrochloride | Tablet;Oral | Pernix Theraps Llc | Manufacturing Change or Addition |
| Velcade | bortezomib | Injectable;Intravenous, Subcutaneous | Millennium Pharms | Efficacy Supplement with Clinical Data to Support |
| Videx | didanosine | For Solution;Oral | Bristol Myers Squibb | Labeling Revision |
| Xanax | alprazolam | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
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