New and Generic Drug Approvals
May 24, 2013
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Calcitriol | calcitriol | Capsule; Oral | Banner Pharmacaps | Approval |
Haldol | haloperidol decanoate | Injectable; Injection | Janssen Pharms | Manufacturing Change or Addition |
Humatrope | somatropin recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
Kombiglyze Xr | metformin hydrochloride; saxagliptin hydrochloride | Tablet, Extended Release; Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
Luvox | fluvoxamine maleate | Tablet; Oral | Ani Pharms | Manufacturing Change or Addition |
Nasacort Aq | triamcinolone acetonide | Spray, Metered; Nasal | Sanofi Aventis Us | Manufacturing Change or Addition |
Onglyza | saxagliptin hydrochloride | Tablet; Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
Plavix | clopidogrel bisulfate | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
Stimate | desmopressin acetate | Spray, Metered; Nasal | Csl Behring | Labeling Revision |
Stimate (Needs No Refrigeration) | desmopressin acetate | Spray, Metered; Nasal | Csl Behring | Labeling Revision |
Trospium Chloride | trospium chloride | Capsule; Oral | Paddock Llc | Approval |
Tysabri | natalizumab | Vial; Single-Use | Biogen Idec | Labeling Revision |
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