New and Generic Drug Approvals
November 14, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Androgel | testosterone | Gel, Metered;Transdermal | Abbvie | Labeling Revision |
| Androgel | testosterone | Gel;Transdermal | Abbvie | Labeling Revision |
| Avastin | bevacizumab | Vial; Intravenous | Genentech | Efficacy Supplement with Clinical Data to Support |
| Campath | alemtuzumab | Vial; Intravenous | Ilex Pharmaceuticals | Labeling Revision |
| Flovent Hfa | fluticasone propionate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Fycompa | perampanel | Tablet;Oral | Eisai Inc | Labeling Revision |
| Obredon | hydrococone bitartrate; guaifenesin | Solution;Oral | Sovereign Pharma Llc | Approval |
| Omniscan | gadodiamide | Injectable;Injection | Ge Healthcare | Labeling Revision |
| Precedex | dexmedetomidine hydrochloride | Injectable;Injection | Hospira | Labeling Revision |
| Precedex | dexmedetomidine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sovaldi | sofosbuvir | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Taxotere | docetaxel | Injectable;Injection | Sanofi Aventis Us | Labeling Revision |
| Tecfidera | dimethyl fumarate | Capsule, Delayed Release;Oral | Biogen Idec Inc | Labeling Revision |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Labeling Revision |
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