What's New on the FDA Drugs Site
August 28, 2012
- CDER Director's Mailbag: Question on Biosimilars
- Current Drug Shortages Index (updated)
- FDA approves Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new combination pill for HIV treatment for some patients
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA)
New and Generic Drug Approvals
August 27, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Capoten | captopril | Tablet; Oral | Par Pharm | Labeling Revision |
| Levetiracetam | levetiracetam | Tablet, Extended Release; Oral | Rouses Point Pharms | Approval |
| Rocuronium Bromide | rocuronium bromide | Injectable; Injection | Tamarang | Approval |
| Stribild | elvitegravir; cobicistat; emtricitabine; tenofovir disoproxil fumarate | Tablet; Combination Fixed Dose | Gilead Sciences Inc | Approval |
| Vicoprofen | hydrocodone bitartrate; ibuprofen | Tablet; Oral | Abbott | Labeling Revision |
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