What's New on the FDA Drugs Site
May 28, 2014
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs (PDF - 280KB)
- JumpStarting Drug Review
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (updated)
- National Drug Code Directory
New and Generic Drug Approvals
May 27, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aloxi | palonosetron hydrochloride | Injectable;Intravenous | Helsinn Hlthcare | Efficacy Supplement with Clinical Data to Support |
| Atovaquone and Proguanil Hydrochloride | atovaquone; proguanil hydrochloride | Tablet;Oral | Mylan Pharms Inc | Approval |
| Diclofenac Sodium | diclofenac sodium | Solution;Topical | Apotex Inc | Approval |
| Nikki | drospirenone;ethinyl estradiol | Tablet;Oral | Lupin Ltd | Approval |
| Pancreaze | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Phoslo | calcium acetate | Capsule;Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Phoslo Gelcaps | calcium acetate | Capsule;Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Synthroid | levothyroxine sodium | Tablet;Oral | Abbvie | Manufacturing Change or Addition |
| Valganciclovir | valganciclovir | Tablet;Oral | Dr Reddys Labs Ltd | Tentative Approval |
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