Latest Fda Approved Drugs Information Systems

FDA approved enzalutamide (XTANDI   Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.  August 31, 2012.   More Information http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm317997.htm

August 30, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Alfuzosin Hydrochloride alfuzosin hydrochloride Tablet, Extended Release; Oral Aurobindo Pharma Approval Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release; Oral Wockhardt Ltd Approval Linzess linaclotide Capsule; Oral Forest Labs Inc Approval Neoral cyclosporine Capsule; Oral Novartis Labeling Revision Neoral cyclosporine Solution; Oral Novartis Labeling Revision Revatio sildenafil citrate Tablet; Oral Pfizer Efficacy Supplement with Clinical Data to Support Revatio sildenafil citrate Solution; Intravenous Pfizer Efficacy Supplement with Clinical Data to Support Revatio sildenafil Suspension; Oral Pfizer Inc Approval Sandimmune cyclosporine Injectable; Injection Novartis Labeling Revision Sandimmune cyclosporine Solution; Oral Novartis Labeling Revision Sandimmune cyclosporine Capsule; Oral Novartis Labeling Revision Subsys fentanyl Spray; Sublingual Insys Thera...

The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes. Granulocytes fight infection. Bosulif is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes.

FDA approved bosutinib tablets (Bosulif, Pfizer, Inc.) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy.   September 4, 2012. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm318203.htm

AUDIENCE : Emergency Medicine, Pharmacy, Patient ISSUE : Sun Pharmaceutical Industries, Inc. recalled one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. No adverse events have been reported at this time. The crystallization of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency. BACKGROUND : Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). The following lot numbers to the consumer level are affected: Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25x4)) Lot Number: 3305.039B, NDC Number: 57664-135-64 (Uni...

August 31, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Azelastine Hydrochloride azelastine hydrochloride Spray, Metered; Nasal Apotex Inc Approval Exelon rivastigmine Film, Extended Release; Transdermal Novartis Efficacy Supplement with Clinical Data to Support Felbatol felbamate Suspension; Oral Meda Pharms Labeling Revision Felbatol felbamate Tablet; Oral Meda Pharms Labeling Revision Mirapex pramipexole dihydrochloride Tablet; Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support Mirapex Er pramipexole dihydrochloride Tablet, Extended Release; Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support Vinorelbine vinorelbine Injectable; Injection Onco Therapies Ltd Approval Xtandi enzalutamide Capsule; Oral Medivation Approval

August 31, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Azelastine Hydrochloride azelastine hydrochloride Spray, Metered; Nasal Apotex Inc Approval Exelon rivastigmine Film, Extended Release; Transdermal Novartis Efficacy Supplement with Clinical Data to Support Felbatol felbamate Suspension; Oral Meda Pharms Labeling Revision Felbatol felbamate Tablet; Oral Meda Pharms Labeling Revision Mirapex pramipexole dihydrochloride Tablet; Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support Mirapex Er pramipexole dihydrochloride Tablet, Extended Release; Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support Vinorelbine vinorelbine Injectable; Injection Onco Therapies Ltd Approval Xtandi enzalutamide Capsule; Oral Medivation Approval

As of October 1, 2012, all firms that manufacture human generic drugs will need to pay user fees to FDA.  User fees are fees paid by industry to FDA to help FDA review manufacturers’ products in a timely manner. FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation.  These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation. For more information, please visit:  GDUFA       documents

September 5, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amlodipine Besylate; Benazepril Hydrochloride amlodipine besylate; benazepril hydrochloride Capsule; Oral Aurobindo Pharma Ltd Approval Declomycin demeclocycline hydrochloride Tablet; Oral Corepharma Labeling Revision Trilipix choline fenofibrate Capsule, Delayed Release; Oral Abbott Labs Labeling Revision Trilipix choline fenofibrate Capsule, Delayed Release; Oral Abbott Labs Manufacturing Change or Addition Ziprasidone Hydrochloride ziprasidone hydrochloride Capsule; Oral Wockhardt Ltd Approval

CLINICAL CONTEXT According to the current study by Jneid and colleagues, new evidence is available on the management of unstable angina. This report replaces the 2007 American College of Cardiology Foundation/American Heart Association (ACC/AHA) Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction (UA/NSTEMI) that were updated by the 2011 guidelines. This guideline was reviewed by 2 official reviewers each nominated by the ACCF and the AHA, as well as 1 or 2 reviewers each from the American College of Emergency Physicians; the Society for Cardiovascular Angiography and Interventions; and the Society of Thoracic Surgeons; and 29 individual content reviewers, including members of the ACCF Interventional Scientific Council. The recommendations in this focused update are considered current until they are superseded in another focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and the ...

CLINICAL CONTEXT The US Food and Drug Administration (FDA) has approved a new colon-cleansing drug, a dual-acting stimulant and osmotic laxative, for colonoscopy preparation. A previously available, low-volume oral phospho-soda preparation was removed from the market for safety reasons. The advantage of a small-volume solution for bowel preparation is greater patient compliance, as use of large-volume cleansing preparations may be a deterrent to some patients for having the procedure. Increased use of screening colonoscopy and cleaner bowel allowing high-quality colonoscopy may improve screening rates and cancer detection. STUDY SYNOPSIS AND PERSPECTIVE The FDA has approved  Prepopik , a new bowel preparation for cleansing the colon before colonoscopy. When it becomes available, the dual-acting stimulant and osmotic laxative will be notable for its low volume, representing "the lowest volume active ingredient colon preparation available — with 10 ounces of prep soluti...