What's New on the FDA Drugs Site
June 21, 2012
- FDA Webinar: 60-Day Draft Guidance Webinar, June 28, 2012 Meeting Information
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Doxorubicin Liposomal (Doxil) Injection (updated)
- Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
- Drug Shortages: Current Drug Shortages: Furosemide Injection
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 2mg/mL (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron 32 mg/50mL premixed bags (updated)
- Drug Shortages: Current Drug Shortages: Sodium Acetate Injection (updated)
- Drug Shortages: Drugs to be Discontinued: Covera HS (180 mg or 240 mg extended-release verapamil HCI) tablets
- Genomics News and Upcoming Events (updated)
- Presentation: FDA and Opioids: What’s a Regulator to Do? (PDF - 398KB)
- Warning Letters 2012 (updated)
New and Generic Drug Approvals
June 20, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actemra | tocilizumab | Injectable; Injection | Genentech | Supplement |
| Efavirenz | efavirenz | Tablet; Oral | Micro Labs Ltd | Tentative Approval |
| Etomidate | etomidate | Injectable; Injection | Bioniche Pharma Usa | Approval |
| Lyrica | pregabalin | Capsule; Oral | Pf Prism | New or Modified Indication |
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