What's New on the FDA Drugs Site
May 28, 2013
- Drugs to be Discontinued (updated)
- Paragraph IV Patent Certifications (updated)
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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