What's New on the FDA Drugs Site
January 31, 2014
- Guidance for Industry: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2014 (PDF - 42KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
- Medication Guides (Updated)
- National Drug Code Directory
- Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
January 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Allegra-D 24 Hour Allergy and Congestion | fexofenadine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Byetta | exenatide synthetic | Injectable;Subcutaneous | Amylin | Manufacturing Change or Addition |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Gonal-F | follitropin alfa/beta | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Iclusig | ponatinib hydrochloride | Tablet;Oral | Ariad | Manufacturing Change or Addition |
| Multaq | dronedarone hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release;Oral | Raptor Pharms | Manufacturing Change or Addition |
| Sandostatin Lar | octreotide acetate | Injectable;Injection | Novartis | Manufacturing Change or Addition |
| Soriatane | acitretin | Capsule;Oral | Stiefel Labs Inc | Labeling Revision |
| Sunitinib Malate | sunitinib malate | Capsule;Oral | Mylan Pharms Inc | Approval |
| Tyzeka | telbivudine | Solution;Oral | Novartis | Manufacturing Change or Addition |
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