What's New on the FDA Drugs Site
March 14, 2014
- Medication Guides (Updated)
- Current Drug Shortages Index (updated)
- Orange Book (updated)
- Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907, April, 1, 2014. FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
New and Generic Drug Approvals
March 13, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Astelin | azelastine hydrochloride | Spray, Metered;Nasal | Meda Pharms | Manufacturing Change or Addition |
| Astepro | azelastine hydrochloride | Spray, Metered;Nasal | Meda Pharms | Manufacturing Change or Addition |
| Clindamycin Palmitate Hydrochloride | clindamycin palmitate hydrochloride | For Solution;Oral | Amneal Pharms | Approval |
| Docetaxel | docetaxel | Injectable;Injection | Pfizer | Approval |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
| Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | Hospira | Labeling Revision |
| Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | Hospira | Labeling Revision |
| Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | Hospira | Labeling Revision |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | Hospira | Labeling Revision |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | Hospira | Labeling Revision |
| Myrbetriq | mirabegron | Tablet, Extended Release;Oral | Apgdi | Manufacturing Change or Addition |
| Noxafil | posaconazole | Injectable;Injection | Merck Sharp Dohme | Approval |
| Sodium Fluoride F-18 | sodium fluoride f-18 | Injectable; Injection | Ucsf Radiopharmaceutical Facility | Approval |
| Taclonex | betamethasone dipropionate; calcipotriene hydrate | Ointment;Topical | Leo Pharma As | Manufacturing Change or Addition |
| Velcade | bortezomib | Injectable;Intravenous, Subcutaneous | Millennium Pharms | Manufacturing Change or Addition |
| Vibativ | telavancin hydrochloride | Powder;Iv (Infusion) | Theravance Inc | Manufacturing Change or Addition |
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