What's New on the FDA Drugs Site
October 23, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA to complete phase-out of chlorofluorocarbon inhalers
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 22, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cerebyx | fosphenytoin sodium | Injectable;Injection | Parke Davis | Labeling Revision |
| Delzicol | mesalamine | Capsule, Delayed Release;Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Fragmin | dalteparin sodium | Injectable;Injection | Eisai Inc | Manufacturing Change or Addition |
| Fragmin | dalteparin sodium | Injectable;Subcutaneous | Eisai Inc | Manufacturing Change or Addition |
| Miralax | polyethylene glycol 3350 | For Solution;Oral | Schering Plough | Manufacturing Change or Addition |
| Risperdal Consta | risperidone | Injectable;Intramuscular | Janssen Pharms | Manufacturing Change or Addition |
| Valium | diazepam | Tablet;Oral | Roche | Labeling Revision |
| 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 |  |
