The latest Regulatory Affairs News & Drug Approvals News articles published daily. Includes news on FDA approvals, EMEA approvals and other regulatory issues. Category added August 2007.
FDA: Boxed Warning On Serious Mental Health Events To Be Required For Chantix And Zyban
05 July 2009
The U.S. Food and Drug Administration announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion)...
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FDA Approves Multaq To Treat Heart Rhythm Disorder
05 July 2009
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders)...
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Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R)
04 July 2009
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug...
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