What's New on the FDA Drugs Site
February 14, 2014
- Current Drug Shortages Index (updated)
- New Drug Shortage: Methylprednisolone Sodium Succinate Injection
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Vimizim (elosulfase alfa) to treat rare congenital enzyme disorder
- FDA Drug Alert: FDA alerts health care professionals and patients of severe adverse events associated with L-citrulline repackaged by Medisca
- How to Report a Shortage or Supply Issue (updated)
- National Drug Code Directory
- Orange Book Current Cumulative Supplement (PDF - 317KB)
New and Generic Drug Approvals
February 13, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Byetta | exenatide synthetic | Injectable;Subcutaneous | Amylin | Manufacturing Change or Addition |
| Children's Advil | ibuprofen | Tablet, Chewable;Oral | Pfizer | Manufacturing Change or Addition |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Barr | Labeling Revision |
| Ilevro | nepafenac | Suspension/Drops;Ophthalmic | Alcon Res Ltd | Manufacturing Change or Addition |
| Junior Strength Advil | ibuprofen | Tablet, Chewable;Oral | Pfizer | Manufacturing Change or Addition |
| Liptruzet | atorvastatin calcium; ezetimibe | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Vascepa | icosapent ethyl | Capsule;Oral | Amarin Pharms | Manufacturing Change or Addition |
| Xarelto | rivaroxaban | Tablet;Oral | Janssen Pharms | Labeling Revision |
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