What's New on the FDA Drugs Site
February 10, 2014
- DDI Webinar - Introduction to Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER - February 11, 2014
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 218KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
February 9, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Vivitrol | naltrexone | For Suspension, Extended Release;Intramuscular | Alkermes | Manufacturing Change or Addition |
February 7, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Agrylin | anagrelide hydrochloride | Capsule;Oral | Shire Llc | Labeling Revision |
| Ammonia N 13 | ammonia n-13 | Injectable;Intravenous | Wa Univ Sch Med | Approval |
| Buspirone Hydrochloride | buspirone hydrochloride | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
| Ceftriaxone and Dextrose In Duplex Container | ceftriaxone sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Ethamolin | ethanolamine oleate | Injectable;Injection | Qol Medcl | Manufacturing Change or Addition |
| Ozurdex | dexamethasone | Implant;Intravitreal | Allergan | Labeling Revision |
| Ritalin | methylphenidate hydrochloride | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Vibativ | telavancin hydrochloride | Powder;Iv (Infusion) | Theravance Inc | Labeling Revision |
| Victrelis | boceprevir | Capsule;Oral | Merck Sharp Dohme | Labeling Revision |
| Zoledronic Acid | zoledronic acid | Injectable;Iv (Infusion) | Acs Dobfar Info Sa | Manufacturing Change or Addition |
| Zytiga | abiraterone acetate | Tablet;Oral | Janssen Biotech | Manufacturing Change or Addition |
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