What's New on the FDA Drugs Site
July 3, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Beleodaq (belinostat) to treat rare, aggressive form of non-Hodgkin lymphoma
- Guidance for Industry: Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF - 356KB)
- National Drug Code Directory
New and Generic Drug Approvals
July 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azor | amlodipine besylate; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Bendamustine Hydrochloride Injection | bendamustine hydrochloride | Injectable; Injection | Eagle Pharms | Tentative Approval |
| Letairis | ambrisentan | Tablet;Oral | Gilead | Manufacturing Change or Addition |
| Norpramin | desipramine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Qualaquin | quinine sulfate | Capsule;Oral | Mutual Pharm Co Inc | Labeling Revision |
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