What's New on the FDA Drugs Site
February 11, 2014
- Directors Mailbag: Answered Questions - 2014
- Electronic Common Technical Document (Updated)
- Medication Guides (Updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)
- National Drug Code Directory
- Orange Book Annual Edition (PDF - 6.9MB)
New and Generic Drug Approvals
February 10, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Astagraf Xl | tacrolimus | Capsule, Extended Release;Oral | Astellas | Labeling Revision |
| Clopidogrel Bisulfate | clopidogrel bisulfate | Tablet; Oral | Macleods Pharms Ltd | Approval |
| Ketorolac Tromethamine | ketorolac tromethamine | Solution; Ophthalmic | Akorn Inc | Approval |
| Nplate | romiplostim | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Omnipaque 140 | iohexol | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 180 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 210 | iohexol | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 240 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 300 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 350 | iohexol | Solution;Injection, Oral | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 70 | iohexol | Solution;Urethral | Ge Healthcare | Manufacturing Change or Addition |
| Rayos | prednisone | Tablet, Delayed Release;Oral | Horizon Pharma | Manufacturing Change or Addition |
| Synribo | omacetaxine mepesuccinate | Powder;Subcutaneous | Ivax Intl | Efficacy Supplement with Clinical Data to Support |
| Zavesca | miglustat | Capsule;Oral | Actelion Pharms Ltd | Labeling Revision |
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