What's New on the FDA Drugs Site
August 6, 2014
- President’s Emergency Plan for AIDS Relief (PEPFAR) (updated with videos)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Chromic Chloride Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Erythrocin Lactobionate Lyophilized Powder for Injection (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Memantine Hydrochloride (Namenda) XR Tablets (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Vitamin A Palmitate (Aquasol A) Injection (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
August 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bimatoprost | bimatoprost | Solution; Ophthalmic | Sandoz Inc | Tentative Approval |
| Loestrin Fe 1.5/30 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-28 | Warner Chilcott Llc | Manufacturing Change or Addition |
| Tenofovir Disoproxil Fumarate | tenofovir disoproxil fumarate | Tablet;Oral | Macleods Pharma | Tentative Approval |
| Vincristine Sulfate Pfs | vincristine sulfate | Injectable;Injection | Hospira | Labeling Revision |
| Zosyn | piperacillin sodium; tazobactam sodium | Injectable;Injection | Wyeth Pharms Inc | Manufacturing Change or Addition |
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