What's New on the FDA Drugs Site
February 22, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA News Release: FDA approves new treatment for late-stage breast cancer
- Guidance for Industry:
- Labeling for Human Prescription Drug and Biological Products -- Implementing the PLR Content and Format Requirements (PDF - 527KB)
- Attachment to: Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data (PDF - 391KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews under FDASIA (updated)
- National Drug Code Directory (updated)
- Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL), February 27, 2013, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information
- Spanish FDA Drug Safety Communication: Actualización del análisis de seguridad sobre el uso de codeína en niños; nueva Advertencia en caja y Contraindicación para su uso después de una amigdalectomía y/o adenoidectomía
New and Generic Drug Approvals
February 21, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atacand | candesartan cilexetil | Tablet; Oral | Astrazeneca | Manufacturing Change or Addition |
| Dificid | fidaxomicin | Tablet; Oral | Optimer Pharms | Manufacturing Change or Addition |
| Fentora | fentanyl citrate | Tablet; Buccal | Cephalon | Efficacy Supplement with Clinical Data to Support |
| Forane | isoflurane | Liquid; Inhalation | Baxter Hlthcare | Manufacturing Change or Addition |
| Gleevec | imatinib mesylate | Tablet; Oral | Novartis | Labeling Revision |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Imodium A-D | loperamide hydrochloride | Tablet; Oral | Mcneil Cons | Manufacturing Change or Addition |
| Kyprolis | carfilzomib | Powder; Intravenous | Onyx Pharms | Manufacturing Change or Addition |
| Niaspan | niacin | Tablet, Extended Release; Oral | Abbvie | Labeling Revision |
| Niaspan Titration Starter Pack | niacin | Tablet, Extended Release; Oral | Abbvie | Labeling Revision |
| Phoslo | calcium acetate | Capsule; Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Phoslo Gelcaps | calcium acetate | Capsule; Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Simcor | niacin; simvastatin | Tablet, Extended Release; Oral | Abbvie | Labeling Revision |
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