What's New on the FDA Drugs Site
April 18, 2014
- Approved Risk Evaluation and Mitigation Strategies (REMS) Page (updated)
- Current Drug Shortages Index (updated)
- New Drug Shortage: Disopyramide Phosphate (Norpace) CR
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Medication Guides (Updated)
- MedWatch Safety Alert: Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
- National Drug Code Directory
New and Generic Drug Approvals
April 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aranesp | darbepoetin alfa | Vial; Intravenous | Amgen | Labeling Revision |
| Aranesp | darbepoetin alfa | Vial; Subcutaneous | Amgen | Labeling Revision |
| Arzerra | ofatumumab | Injectable; Injection | Glaxo Grp Ltd | Efficacy Supplement with Clinical Data to Support |
| Coartem | artemether; lumefantrine | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered;Inhalation | Merck Sharp Dohme | Labeling Revision |
| Nicorette | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Nicorette | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Nicorette (Mint) | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Nicorette (Mint) | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Phenytoin | phenytoin | Tablet, Chewable, Tablet;Oral | Taro Pharma | Approval |
| Trental | pentoxifylline | Tablet, Extended Release;Oral | Sanofi Aventis Us | Labeling Revision |
| Vasostrict | vasopressin | Injectable; Injection | Par Sterile Products Llc | Approval |
| Viibryd | vilazodone hydrochloride | Tablet;Oral | Forest Labs Inc | Manufacturing Change or Addition |
| Vivitrol | naltrexone | For Suspension, Extended Release;Intramuscular | Alkermes | Manufacturing Change or Addition |
| Zytiga | abiraterone acetate | Tablet;Oral | Janssen Biotech | Manufacturing Change or Addition |
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