February 22, 2010
Star Scientific announced that it has filed an application with the FDA for approval to market Ariva-BDL as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009.
July 23, 2009
The FDA has notified healthcare professionals and patients that a laboratory analysis of electronic cigarette cartridge samples has found that they contain carcinogens (eg, nitrosamines) and diethylene glycol, a toxic chemical found in antifreeze.
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.
September 02, 2010
Abbott announced that the FDA has approved its RealTime HBV assay for measuring the amount of hepatitis B virus (HBV) in human plasma or serum from individuals chronically infected with HBV.