New and Generic Drug Approvals
August 28, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aleve Pm | diphenhydramine hydrochloride; naproxen sodium | Tablet;Oral | Bayer Hlthcare | Labeling Revision |
| Avonex | interferon beta-1a | Vial | Biogen | Labeling Revision |
| Decitabine | decitabine | Injectable;Injection | Sandoz Inc | Approval |
| Ella | ulipristal acetate | Tablet;Oral | Lab Hra Pharma | Labeling Revision |
| Frovatriptan Succinate | frovatriptan succinate | Tablet;Oral | Mylan Pharms Inc | Approval |
| Ifex | ifosfamide | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Ifex/Mesnex Kit | ifosfamide; mesna | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Lamivudine and Zidovudine | lamivudine;zidovudine | Tablet;Oral | Mylan Pharms Inc | Approval |
| Metformin Hydrochloride | metformin hydrochloride | Tablet;Oral | Zydus Hlthcare | Approval |
| Oxycodone; Acetaminophen | oxycodone;acetaminophen | Tablet;Oral | Rhodes Pharms | Approval |
| Requip | ropinirole hydrochloride | Tablet;Oral | Glaxosmithkline Llc | Labeling Revision |
| Requip Xl | ropinirole hydrochloride | Tablet, Extended Release;Oral | Glaxosmithkline Llc | Labeling Revision |
| Rimso-50 | dimethyl sulfoxide | Solution;Intravesical | Mylan Institutional | Manufacturing Change or Addition |
| Stavzor | valproic acid | Capsule, Delayed Release;Oral | Banner Pharmacaps | Labeling Revision |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Efficacy Supplement with Clinical Data to Support |
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