What's New on the FDA Drugs Site
July 20, 2015
- Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Medication Guides (updated)
New and Generic Drug Approvals
July 17, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Krystexxa | pegloticase | Injectable; Injection | Savient Pharms | Labeling Revision |
| Lantus | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Lantus Solostar | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Lexiva | fosamprenavir calcium | Tablet;Oral | Viiv Hlthcare | Labeling Revision |
| Lexiva | fosamprenavir calcium | Suspension;Oral | Viiv Hlthcare | Labeling Revision |
| Linezolid | linezolid | Injectable;Injection | Sandoz | Approval |
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Wednesday, July 22, 2015
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