What's New on the FDA Drugs Site
February 27, 2012
- Drug Firm Annual Registration Status Download File (ZIP - 386KB)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Atracurium besylate (updated)
- Drug Shortages: Current Drug Shortages: Cosyntropin Injection (updated)
- Drug Shortages: Current Drug Shortages: Labetalol Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Orphenadrine Citrate Injection (updated)
- MedWatch Safety Alert: Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen
New and Generic Drug Approvals
February 24, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Elestrin | estradiol | Gel, Metered; Transdermal | Azur Pharma Ii | Labeling Revision |
| Naltrexone Hydrochloride | naltrexone hydrochloride | Tablet; Oral | Sun Pharma Global | Approval |
| Ozurdex | dexamethasone | Implant; Intravitreal | Allergan | Labeling Revision |
| Xalkori | crizotinib | Capsule; Oral | Pfizer | Labeling Revision |
| Xiaflex | collagenase clostridium histolyticum | Solution; Injection | Auxilium Pharms | Labeling Revision |
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