What's New on the FDA Drugs Site
January 23, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug ShortagesFDA Statement: FDA announces meeting of Pharmacy Compounding Advisory Committee
- Dihydroergotamine Mesylate Injection (Updated - Resolved)
- Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL Due to Particulate Matter
- National Drug Code Directory
New and Generic Drug Approvals
January 22, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Calcium Acetate | calcium acetate | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
| Doxil (Liposomal) | doxorubicin hydrochloride | Injectable, Liposomal;Injection | Janssen Res and Dev | Manufacturing Change or Addition |
| Raloxifene Hydrochloride | raloxifene hydrochloride | Tablet;Oral | Watson Labs Inc | Approval |
| Xopenex | levalbuterol hydrochloride | Solution;Inhalation | Oak Pharms Inc | Efficacy Supplement with Clinical Data to Support |
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Monday, January 26, 2015
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