What's New on the FDA Drugs Site
May 14, 2015
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Chloroquine Phosphate Tablets (New - Currently in Shortage)
- Inactive Ingredient Search for Approved Drug Products Search
- Inactive Ingredients Database Download
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
May 13, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Akynzeo | netupitant; palonosetron hydrochloride | Capsule;Oral | Helsinn Hlthcare | Labeling Revision |
| Aloprim | allopurinol sodium | Injectable;Injection | Mylan Institutional | Manufacturing Change or Addition |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium; Levomefolate Calcium | drospirenone;ethinyl estradiol;levomefolate calcium;levomefolate calcium | Tablet;Oral | Watson Labs Inc | Tentative Approval |
| Lamivudine and Zidovudine | lamivudine and zidovudine | Tablet; Oral | Strides Arcolab Ltd | Approval |
| Lamivudine and Zidovudine | lamivudine; zidovudine | Tablet;Oral | Strides Arcolab Ltd | Approval |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Stendra | avanafil | Tablet;Oral | Vivus | Labeling Revision |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Venofer | iron sucrose | Injectable;Intravenous | Luitpold | Manufacturing Change or Addition |
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Friday, May 15, 2015
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