July 01, 2009
The FDA has notified healthcare professionals and patients that it has required manufacturers of varenicline (Chantix, from Pfizer) and bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban, from GlaxoSmithKline) to add new Boxed Warnings to the product labeling and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms.
January 18, 2008
The labeling for Chantix (varenicline tartrate, from Pfizer) has been updated with a warning to observe patients for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.
February 09, 2010
The FDA has approved Crestor (rosuvastatin calcium tablets, from AstraZeneca) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
February 08, 2010
Talecris Biotherapeutics was granted orphan drug designation by the FDA for the development of an aerosol formulation of alpha1-proteinease inhibitor to treat congenital alpha1-antitrypsin (AAT) deficiency.
February 08, 2010
Genta Incorporated announced initiation of treatment in a Phase 2 trial of tesetaxel in advanced melanoma.