What's New on the FDA Drugs Site
May 20, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- First-Time Generic Drug Approvals - April 2013
- Generic Drugs: Suitability Petition Reports (updated)
-
MedWatch Safety Alert: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
- National Drug Code Directory
New and Generic Drug Approvals
May 17, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Angiomax | bivalirudin | Injectable; Intravenous | Medicines Co | Labeling Revision |
| Lamivudine; Tenofovir Disoproxil Fumarate | lamivudine; tenofovir disoproxil fumarate | Tablet; Oral | Ranbaxy Labs Ltd | Tentative Approval |
| Levetiracetam | levetiracetam | Tablet, Extended Release; Oral | Apotex Inc | Tentative Approval |
| Tasigna | nilotinib hydrochloride monohydrate | Capsule; Oral | Novartis | Labeling Revision |
| Ultravate | halobetasol propionate | Ointment; Topical | Ranbaxy | Manufacturing Change or Addition |
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