New and Generic Drug Approvals
September 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Besivance | besifloxacin hydrochloride | Suspension/Drops;Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
| Campath | alemtuzumab | Vial; Intravenous | Ilex Pharmaceuticals | Labeling Revision |
| Cerezyme | imiglucerase | Injectable;Injection | Genzyme | Manufacturing Change or Addition |
| Ferric Citrate | ferric citrate | Tablet;Oral | Keryx Biopharma Inc | Approval |
| Lantus | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Lantus Solostar | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Mirvaso | brimonidine tartrate | Gel;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Mucinex Dm | dextromethorphan hydrobromide; guaifenesin | Tablet, Extended Release;Oral | Reckitt Benckiser | Manufacturing Change or Addition |
| Olysio | simeprevir sodium | Capsule;Oral | Janssen Prods | Labeling Revision |
| Pegasys | peginterferon alfa-2a | Syringe | Hoffman-La Roche | Labeling Revision |
| Pegasys | peginterferon alfa-2a | Vial; Subcutaneous | Hoffman-La Roche | Labeling Revision |
No comments:
Post a Comment