-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/4/2011 8:24:00 PM
To: guyperea@live.com
Subject: CDER New November 4, 2011
What's New on the FDA Drugs Site
November 4, 2011
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
(http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm)- Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la revisión de seguridad de Chantix (vareniclina) y el riesgo de efectos neuropsiquiátricos adversos
- Drug and Biologic Approval Reports
- CDER Drug and Biologic Approvals for Calendar Year 2011
- CDER New Molecular Entity (NME) and New Biologic Approvals Calendar Year 2011
- CDER Priority Drug and Biologic Approvals in Calendar Year 2011
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2011
- Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics) 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- FDA approves Xarelto (rivaroxaban) to prevent stroke in people with common type of abnormal heart rhythm
- FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program
- FDA Drug Safety Podcast for Healthcare Professionals: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
- Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS) (updated)
November 3, 2011
- Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
- Drug Shortages: Current Drug Shortages: Daunorubicin hydrochloride solution for injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Doxorubicin (adriamycin) lyophilized powder (updated)
- Drug Shortages: Current Drug Shortages: Etoposide solution for injection (updated)
- Drug Shortages: Current Drug Shortages: Labetalol Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin Powder for Injection (updated)
- Drug Shortages: Current Drug Shortages: Paclitaxel Injection (updated)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
- FDA Drug Safety Podcast for Healthcare Professionals: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
- FDA/CDER issue letters to Otsuka Pharmaceutical Development and Commercialization, Inc. (PDF) and Lantheus Medical Imaging, Inc. (PDF)
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Model Bioequivalence Data Summary Tables (updated)
November 2, 2011
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
(http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm)- Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción farmacológica entre azul de metileno (cloruro de metiltioninio) y medicamentos psiquiátricos serotonérgicos
- Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción farmacológica entre linezolid (Zyvox) y medicamentos psiquiátricos serotonérgicos
- Drug Shortages: Acetylcysteine Inhalation Solution (updated)
- Drug Shortages: Current Drug Shortages: Levofloxacin Injection (updated)
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Drugs@FDA Download File (updated)
- Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
November 1, 2011
- Drug Development and Drug Interactions: Possible Models for Decision-Making (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Guidance for Industry: Q8, Q9, and Q10 Questions and Answers (PDF - 185KB)
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
(http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm)- Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización de la revisión de seguridad con respecto al posible incremento del riesgo de coágulos de sangre por el uso de pÃldoras anticonceptivas que contienen drospirenona
- Drug Shortages: Current Drug Shortages: Levaquin Injection (updated)
- Drug Shortages: Current Drug Shortages: Levofloxacin Injection (updated)
- Drug Shortages: Current Drug Shortages: Mesna 100 mg/mL Injection
- Drug Shortages: Current Drug Shortages: Pancuronium Bromide Injection
- FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
- Medication Guides (updated)
October 31, 2011
- Drug Shortages (updated)
- Fact Sheet: Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S.
- Executive Order -- Reducing Prescription Drug Shortages
- Letter to Industry
- FDA Report: A Review of FDA's Approach to Medical Product Shortages
- Center for Drug Evaluation and Research’s (CDER) Drug Shortages Action Plan
- Economic Analysis of the Causes of Drug Shortages (HHS)
- BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
- Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts, ER Capsules (updated)
- Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
- Drug Shortages: Current Drug Shortages: Calcium Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
- Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection (updated)
- Drug Shortages: Current Drug Shortages: Labetalol Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Levaquin Injection (updated)
- Drug Shortages: Current Drug Shortages: Levofloxacin Injection (updated)
- Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Nalbuphine Injection (updated)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Preventing Surgical Fires: Initiative Partners (updated)
New and Generic Drug Approvals
November 4, 2011
- Acephen (acetaminophen) Suppository, G & W Laboratories, Inc., Labeling Revision
- Amturnide (aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Calan (verapamil hydrochloride) Injection, Pfizer, Inc., Labeling Revision
- Calan (verapamil hydrochloride) Injection, Pfizer, Inc., Labeling Revision
- Calan (verapamil hydrochloride) Tablets, Pfizer, Inc., Labeling Revision
- Covera-HS (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Inc., Labeling Revision
- Methotrexate LPF (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision
- Methotrexate Preservative Free (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision
- Methotrexate Sodium Injection, Hospira, Inc., Labeling Revision
- Methotrexate Sodium Preservative Free (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision
- Prometrium (progesterone) Capsules, Abbott Products, Inc., Labeling Revision
- Risperidone Orally Disintegrating Tablets, Jubilant Life Sciences, Ltd., Approval
- Tasigna (nilotinib) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
- Toviaz (fesoterodine fumarate) Extended-Release Tablets, Pfizer, Inc., Labeling Revision
- Tranexamic Acid Injection, Mylan Institutional, LLC, Approval
- Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision
- Valstar (valrubicin) Intravesical Solution, Endo Pharmaceuticals Solutions, Inc., Labeling Revision
- Velcade (bortezomib) Injection, Millennium Pharmaceuticals, Inc., Labeling Revision
- Xarelto (rivaroxaban) Tablets, Janssen Pharmaceuticals, Inc., Approval
November 3, 2011
- Azor (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
- Demerol (meperidine hydrocholoride) Injection, Sanofi-Aventis, LLC, Labeling Revision
- Exforge (amlodipine and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Lipofen (fenofibrate) Capsules, Cipher Pharmaceuticals, Inc., Labeling Revision
- Norvasc ((amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision
- Prevacid 24HR (lansoprazole) Capsules, Novartis Consumer Health, Inc., Labeling Revision
- Solifenacin Succinate Tablets, Teva Pharmaceuticals USA, Inc., Tentative Approval
- Zoledronic Acid Injection, Dr. Reddy’s Laboratories Ltd., Tentative Approval
November 1, 2011
- Epinastine Hydrochloride Ophthalmic Solution, Apotex Inc., Approval
- Epinastine Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Approval
- Epinastine Hydrochloride Ophthalmic Solution, Sun Pharmaceutical Industries Ltd., Approval
- Naproxen Sodium Tablets, Aurobindo Pharma Ltd., Approval
- Tramadol Hydrochloride Extended-Release Tablets, Lupin Ltd., Approval
October 31, 2011
- Diltiazem Hydrochloride Extended-Release Capsules, Sun Pharma Global, Approval
- Doxorubicin Hydrochloride Injection, Onco Therapies Limited, Approval
- Exparel (bupivacaine liposome) Injectable Suspension, Pacira Pharmaceuticals, Inc., Approval
- Felodipine Extended-Release Tablets, Endo Pharmaceuticals Inc., Approval
- Leukeran (chlorambucil) Tablet, Smithkline Beecham, Labeling Revision
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