What's New on the FDA Drugs Site
June 6, 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)
- Manual of Policies and Procedures (MAPP) 4642.3 Student Volunteer Employment Program (SVEP) (PDF - 64KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- National Drug Code Directory
- Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination
New and Generic Drug Approvals
June 5, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acetadote | acetylcysteine | Injectable; Intravenous | Cumberland Pharms | Labeling Revision |
| Alphagan P | brimonidine tartrate | Solution/Drops; Ophthalmic | Allergan | Manufacturing Change or Addition |
| Ambien | zolpidem tartrate | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Apidra | insulin glulisine recombinant | Injectable; Iv (Infusion)-Sc | Sanofi Aventis Us | Manufacturing Change or Addition |
| Apidra Solostar | insulin glulisine recombinant | Injectable; Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition |
| Cefoxitin and Dextrose In Duplex Container | cefoxitin sodium | Injectable; Injection | B Braun | Labeling Revision |
| Claritin | loratadine | Tablet; Oral | Schering Plough | Manufacturing Change or Addition |
| Claritin Hives Relief | loratadine | Tablet; Oral | Schering Plough | Manufacturing Change or Addition |
| Haldol | haloperidol decanoate | Injectable; Injection | Janssen Pharms | Manufacturing Change or Addition |
| Lantus | insulin glargine recombinant | Injectable; Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Levofloxacin | levofloxacin | Injectable; Injection | Claris Lifesciences | Approval |
| Lovenox | enoxaparin sodium | Injectable; Intravenous, Subcutaneous | Sanofi Aventis Us | Labeling Revision |
| Lovenox (Preservative Free) | enoxaparin sodium | Injectable; Subcutaneous | Sanofi Aventis Us | Labeling Revision |
| Nizoral | ketoconazole | Shampoo; Topical | Janssen Pharms | Manufacturing Change or Addition |
| Revlimid | lenalidomide | Capsule; Oral | Celgene | New or Modified Indication |
| Sporanox | itraconazole | Capsule; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Uvadex | methoxsalen | Injectable; Injection | Therakos | Manufacturing Change or Addition |
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