What's New on the FDA Drugs Site
August 19, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert - Aidapak Services LLC, Selected Repackaged Pharmaceuticals by Aidapack: Recall - Potential Incorrect Labeling
- MedWatch Safety Alert - UPDATE All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
- National Drug Code Directory
New and Generic Drug Approvals
August 16, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Besivance | besifloxacin hydrochloride | Suspension/Drops; Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
| Diabeta | glyburide | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Firmagon | degarelix acetate | Powder; Subcutaneous | Ferring | Labeling Revision |
| Flagyl | metronidazole | Tablet; Oral | Gd Searle Llc | Labeling Revision |
| Flagyl | metronidazole | Capsule; Oral | Gd Searle Llc | Labeling Revision |
| Flagyl Er | metronidazole | Tablet, Extended Release; Oral | Gd Searle Llc | Labeling Revision |
| Flagyl I.V. | metronidazole hydrochloride | Injectable; Injection | Pfizer | Labeling Revision |
| Flagyl I.V. Rtu In Plastic Container | metronidazole | Injectable; Injection | Pfizer | Labeling Revision |
| Gliadel | carmustine | Implant; Intracranial | Arbor Pharms Llc | Labeling Revision |
| Omeprazole | omeprazole | Tablet, Delayed Release; Oral | Dexcel Pharma | Labeling Revision |
| Oxytrol For Women | oxybutynin | Film, Extended Release; Transdermal | Msd Consumer | Manufacturing Change or Addition |
| Progesterone | progesterone | Capsule; Oral | Banner Pharmacaps | Approval |
| Prograf | tacrolimus | Injectable; Injection | Astellas | Manufacturing Change or Addition |
| Trokendi Xr | topiramate | Capsule, Extended Release; Oral | Supernus Pharmaceuticals Inc. | Approval |
| Vogelxo | testosterone | Gel; Topical | Upsher Smith Labs | Tentative Approval |
| Zoledronic Acid | zoledronic acid | Injectable; Iv (Infusion) | Pharmaceutics | Approval |
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