New and Generic Drug Approvals
September 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Armodafinil | armodafinil | Tablet;Oral | Teva Pharms Usa Inc | Tentative Approval |
| Benzonatate | benzonatate | Capsule;Oral | Thepharmanetwork Llc | Approval |
| Diovan | valsartan | Capsule;Oral | Novartis | Labeling Revision |
| Diovan Hct | hydrochlorothiazide; valsartan | Tablet;Oral | Novartis | Labeling Revision |
| Exforge | amlodipine besylate; valsartan | Tablet;Oral | Novartis | Labeling Revision |
| Exforge Hct | amlodipine besylate; hydrochlorothiazide; valsartan | Tablet;Oral | Novartis | Labeling Revision |
| Fortaz | ceftazidime | Injectable;Injection | Covis Injectables | Labeling Revision |
| Fortaz In Plastic Container | ceftazidime sodium | Injectable;Injection | Covis Injectables | Labeling Revision |
| Fosrenol | lanthanum carbonate | Tablet, Chewable;Oral | Shire Llc | Labeling Revision |
| Fosrenol | lanthanum carbonate | Powder;Oral | Shire Development | Labeling Revision |
| Naftin | naftifine hydrochloride | Gel;Topical | Merz Pharms | Manufacturing Change or Addition |
| Raloxifene Hydrochloride | raloxifene hydrochloride | Tablet; Oral | Invagen Pharms | Approval |
| Spiriva Respimat | tiotropium bromide | Spray, Metered;Inhalation | Boehringer Ingelheim | Approval |
| Sterile Water In Plastic Container | sterile water for irrigation | Liquid;Irrigation | Hospira | Manufacturing Change or Addition |
| Tybost | cobicistat | Tablet;Oral | Gilead Sciences Inc | Efficacy Supplement with Clinical Data to Support |
| Velphoro | sucroferric oxyhydroxide | Tablet, Chewable;Oral | Vifor Fresenius | Labeling Revision |
| Vibramycin | doxycycline hyclate | Injectable;Injection | Pfizer | Labeling Revision |
| Vitekta | elvitegravir | Tablet;Oral | Gilead Sciences Inc | Approval |
| Xylocaine Viscous | lidocaine hydrochloride | Solution;Oral | Fresenius Kabi Usa | Labeling Revision |
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