What's New on the FDA Drugs Site
August 29, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Download File (updated)
- FDA Notification to the Cystic Fibrosis Community on Kalydeco (ivacaftor)
- Natural Disaster Response (updated)
New and Generic Drug Approvals
August 28, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clindamycin Palmitate Hydrochloride | clindamycin palmitate hydrochloride | For Solution; Oral | Lyne | Approval |
| Flumazenil | flumazenil | Injectable; Injection | Sagent Pharms | Approval |
| Kalydeco | ivacaftor | Tablet; Oral | Vertex Pharms | Labeling Revision |
| Nucynta Er | tapentadol hydrochloride | Tablet, Extended Release; Oral | Janssen Pharms | Efficacy Supplement with Clinical Data to Support |
| Topotecan Hydrochloride | topotecan hydrochloride | Injectable; Injection | Onco Therapies Ltd | Approval |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
