What's New on the FDA Drugs Site
April 30, 2013
- CDER Billable Biologic Product List (PDF - 48KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Safety Podcast: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration
- Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
- FDA Listing of Authorized Generics (updated)
- FDA News Release: FDA approves Procysbi for rare genetic condition
- Medication Guides (updated)
- MedWatch Safety Alert - Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution
- National Drug Code Directory (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
- Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): 1 new and 8 updated reports (updated)
New and Generic Drug Approvals
April 29, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actemra | tocilizumab | Injectable; Injection | Genentech | Efficacy Supplement with Clinical Data to Support |
| Amlodipine Besylate | amlodipine besylate | Tablet; Oral | Accord Hlthcare | Approval |
| Amlodipine Besylate; Valsartan | amlodipine besylate; valsartan | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Coartem | artemether; lumefantrine | Tablet; Oral | Novartis | Labeling Revision |
| Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Dextroamphetamine Sulfate; Amphetamine Sulfate | dextroamphetamine saccharate; amphetamine aspartate monohydrate; dextroamphetamine sulfate; amphetamine sulfate | Capsule, Extended Release; Oral | Teva Pharms Usa | Approval |
| Esomeprazole Strontium | esomeprazole strontium | Capsule, Delayed Release; Oral | Hanmi Usa Inc | Tentative Approval |
| Fortaz In Plastic Container | ceftazidime sodium | Injectable; Injection | Covis Pharma | Manufacturing Change or Addition |
| Metoprolol Tartrate | metoprolol tartrate | Injectable; Injection | Claris Lifesciences | Approval |
| Nexterone | amiodarone hydrochloride | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Ofloxacin | ofloxacin | Solution/Drops; Ophthalmic | Altaire Pharms Inc | Approval |
| Quinapril Hydrochloride | quinapril hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Rhinocort | budesonide | Spray, Metered; Nasal | Astrazeneca | Manufacturing Change or Addition |
| Stelara | ustekinumab | Injectable; Injection | Centocor Ortho Biotech Inc | Labeling Revision |
| Sulfamethoxazole and Trimethoprim | sulfamethoxazole; trimethoprim | Injectable; Injection | Teva Pharms Usa | Labeling Revision |
| Vibra-Tabs | doxycycline hyclate | Tablet; Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline | For Suspension; Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline hyclate | Capsule; Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline calcium | Suspension; Oral | Pfizer | Labeling Revision |
| Zemuron | rocuronium bromide | Injectable; Injection | Organon Usa Inc | Manufacturing Change or Addition |
| Zinacef In Plastic Container | cefuroxime sodium | Injectable; Injection | Covis Pharma | Manufacturing Change or Addition |
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