New and Generic Drug Approvals
November 21, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adcetris | brentuximab vedotin | Injectable; Injection | Seattle Genetics | Labeling Revision |
| Cardizem | diltiazem hydrochloride | Tablet;Oral | Valeant Intl | Labeling Revision |
| Hydrocodone Bitartrate and Homatropine Methylbromide | homatropine methylbromide; hydrocodone bitartrate | Syrup;Oral | Actavis Mid Atlantic | Labeling Revision |
| Sensipar | cinacalcet hydrochloride | Tablet;Oral | Amgen | Efficacy Supplement with Clinical Data to Support |
| Sensipar | cinacalcet hydrochloride | Tablet;Oral | Amgen | Labeling Revision |
| Testosterone Enanthate | testosterone enanthate | Injectable;Injection | Hikma Farmaceutica | Labeling Revision |
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