What's New on the FDA Drugs Site
September 13, 2012
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Download File (updated)
- FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
- FDA approves Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS)
- FDA approves the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer
- Prescription Drug User Fee Act (PDUFA):
- Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications (updated to incorporate FY 2011 standard costs)
- Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications (updated to incorporate FY 2011 standard costs) (PDF version - 14KB)
- Federal Register Notice: Fee for Using a Priority Review Voucher in FY 2013 (PDF - 191KB)
- Spanish FDA Drug Safety Communication: Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular
September 12, 2012
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS), September 13, 2012, Teleconference. Meeting information
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- MedWatch Safety Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets
New and Generic Drug Approvals
September 12, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aubagio | teriflunomide | Tablet; Oral | Sanofi Aventis Us | Approval |
| Avapro | irbesartan | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Choline C 11 | choline c 11 | Injectable; Injection | Mayo Clinic Mcprf | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Sti Pharma Llc | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Jubilant Organosys | Approval |
| Olanzapine | olanzapine | Tablet, Orally Disintegrating; Oral | Jubilant Organosys | Approval |
| Tarka | trandolapril; verapamil hydrochloride | Tablet, Extended Release; Oral | Abbott | Labeling Revision |
| Teveten | eprosartan mesylate | Tablet; Oral | Abbott | Labeling Revision |
| Teveten Hct | eprosartan mesylate; hydrochlorothiazide | Tablet; Oral | Abbott | Labeling Revision |
September 11, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Lupin Ltd | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Invagen Pharms | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Hikma Pharms | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Apotex Inc | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Torrent Pharms Ltd | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Macleods Pharms Ltd | Approval |
| Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Accord Hlthcare | Approval |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Emcure Pharms Ltd | Approval |
| Mavik | trandolapril | Tablet; Oral | Abbott | Labeling Revision |
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