What's New on the FDA Drugs Site
November 1, 2013
- FDA Drug Safety Podcast: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales
- FDA Drug Safety Podcast: FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration
- FDA approves Gazyva for chronic lymphocytic leukemia
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Medical Gas Regulation Review; Announcement of Public Meeting, December 6, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
- National Drug Code Directory
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
October 31, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aczone | dapsone | Gel;Topical | Allergan | Manufacturing Change or Addition |
| Adriamycin Pfs | doxorubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Adriamycin Rdf | doxorubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Dextrose 5% In Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Duexis | famotidine; ibuprofen | Tablet;Oral | Horizon Pharma | Labeling Revision |
| Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Hetero Labs Ltd V | Tentative Approval |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Fuzeon | enfuvirtide | Injectable;Subcutaneous | Roche | Labeling Revision |
| Klonopin | clonazepam | Tablet;Oral | Roche | Labeling Revision |
| Klonopin Rapidly Disintegrating | clonazepam | Tablet, Orally Disintegrating;Oral | Roche | Labeling Revision |
| Lopid | gemfibrozil | Capsule;Oral | Pfizer Pharms | Labeling Revision |
| Lopid | gemfibrozil | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Nicoderm Cq | nicotine | Film, Extended Release;Transdermal | Sanofi Aventis Us | Labeling Revision |
| Novolog | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Flexpen | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Innolet | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Penfill | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Nucynta | tapentadol hydrochloride | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Prezista | darunavir ethanolate | Tablet;Oral | Janssen Prods | Manufacturing Change or Addition |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release;Oral | Raptor Pharms | Manufacturing Change or Addition |
| Tolterodine Tartrate | tolterodine tartrate | Capsule, Extended Release;Oral | Mylan Pharms Inc | Approval |
| Uvadex | methoxsalen | Injectable;Injection | Therakos | Labeling Revision |
| Vancomycin Hydrochloride | vancomycin hydrochloride | Injectable;Injection | Emcure Pharms Ltd | Approval |
| Vancomycin Hydrochloride | vancomycin hydrochloride | Injectable;Injection | Emcure Pharms Ltd | Approval |
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