What's New on the FDA Drugs Site
June 02, 2014
- Current Drug Shortages Index (updated)
- New Drug Shortage: Dextrose Injection Bags, 5%
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
- National Drug Code Directory
New and Generic Drug Approvals
May 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify Maintena Kit | aripiprazole | For Suspension, Extended Release;Intramuscular | Otsuka Pharm Co Ltd | Manufacturing Change or Addition |
| Aggrenox | aspirin; dipyridamole | Capsule, Extended Release;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Celecoxib | celecoxib | Capsule; Oral | Teva Pharms | Approval |
| Celecoxib | celecoxib | Capsule; Oral | Mylan Pharma | Approval |
| Celecoxib | celecoxib | Capsule; Oral | Mylan Pharma | Tentative Approval |
| Diovan Hct | hydrochlorothiazide; valsartan | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Dostinex | cabergoline | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Famotidine | famotidine | Suspension;Oral | Hi-Tech Pharmacal | Approval |
| Humira | adalimumab | Syringe | Abbvie Inc | Labeling Revision |
| Humira | adalimumab | Vial | Abbvie Inc | Labeling Revision |
| Jakafi | ruxolitinib phosphate | Tablet;Oral | Incyte Corp | Manufacturing Change or Addition |
| Linezolid | linezolid | Injectable;Injection | Sandoz | Tentative Approval |
| Omidria | phenylephrine;ketorolac | Injectable;Injection | Omeros Corp | Approval |
| Tamiflu | oseltamivir phosphate | Capsule;Oral | Roche | Labeling Revision |
| Tamiflu | oseltamivir phosphate | For Suspension;Oral | Roche | Labeling Revision |
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