New and Generic Drug Approvals
September 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azor | amlodipine besylate; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Benicar | olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Benicar Hct | hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Humira | adalimumab | Syringe | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Humira | adalimumab | Vial | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Methylphenidate Hydrochloride | methylphenidate hydrochloride | Tablet;Oral | Vintage Pharms | Approval |
| Minivelle | estradiol | Film, Extended Release;Transdermal | Noven | Efficacy Supplement with Clinical Data to Support |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Manufacturing Change or Addition |
| Otezla | apremilast | Injectable;Injection | Celgene Corp | Approval |
| Ropivacaine Hydrochloride | ropivacaine hydrochloride | Injectable;Injection | Hospira Inc | Approval |
| Ropivacaine Hydrochloride | ropivacaine hydrochloride | Injectable; Injection | Sagent Pharms | Approval |
| Topotecan Hydrochloride | topotecan hydrochloride | Solution;Intravenous | Teva Pharms Usa | Manufacturing Change or Addition |
| Tribenzor | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Zanosar | streptozocin | Injectable;Injection | Teva Pharms Usa | Manufacturing Change or Addition |
| Zelboraf | vemurafenib | Tablet;Oral | Hoffmann La Roche | Manufacturing Change or Addition |
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