What's New on the FDA Drugs Site
June 29, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)
- FDA MedWatch Safety Alert: Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter
- Medication Guides (updated)
New and Generic Drug Approvals
June 28, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amphadase | hyaluronidase | Injectable; Injection | Amphastar Pharm | Labeling Revision |
| Bepreve | bepotastine besilate | Solution/Drops; Ophthalmic | Ista Pharms | Labeling Revision |
| Doxepin Hydrochloride | doxepin hydrochloride | Tablet; Oral | Par Pharm | Tentative Approval |
| Myrbetriq | mirabegron | Tablet, Extended Release; Oral | Astellas | Approval |
| Promethazine Hydrochloride | promethazine hydrochloride | Solution; Oral | Tris Pharma Inc | Approval |
| Promethazine Hydrochloride; Dextromethorphan Hydrobromide | promethazine hydrochloride; dextromethorphan hydrobromide | Tablet, Chewable, Tablet, Capsule; Oral | Tris Pharma Inc | Approval |
| Remicade | infliximab | Vial | Centocor Inc | Labeling Revision |
| Visudyne | verteporfin | Injectable; Injection | Qlt | Labeling Revision |
| Zemplar | paricalcitol | Capsule; Oral | Abbott | Manufacturing Change or Addition |
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