New and Generic Drug Approvals
October 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Argatroban | argatroban | Injectable;Injection | Hikma Pharm Co Ltd | Manufacturing Change or Addition |
| Cymbalta | duloxetine hydrochloride | Capsule, Delayed Rel Pellets;Oral | Lilly | Efficacy Supplement with Clinical Data to Support |
| Fiorinal | aspirin; butalbital; caffeine | Capsule;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Fiorinal | aspirin; butalbital; caffeine | Tablet;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Hylenex Recombinant | hyaluronidase recombinant human | Injectable;Injection | Halozyme Therap | Manufacturing Change or Addition |
| Ilaris | canakinumab | Injectable; Subcutaneous | Novartis Pharms | Labeling Revision |
| Indocin | indomethacin | Suspension;Oral | Iroko Pharms | Manufacturing Change or Addition |
| Lialda | mesalamine | Tablet, Delayed Release;Oral | Shire | Labeling Revision |
| Megace Es | megestrol acetate | Suspension;Oral | Par Pharm | Manufacturing Change or Addition |
| Vascepa | icosapent ethyl | Capsule;Oral | Amarin Pharms | Manufacturing Change or Addition |
| Xeloda | capecitabine | Tablet;Oral | Hoffmann La Roche | Labeling Revision |
No comments:
Post a Comment