March 15, 2010
The FDA has notified healthcare professionals and patients that a Boxed Warning has been added to the Plavix (clopidogrel tablets, from Bristol-Myers Squibb and Sanofi) Prescribing Information to include information about reduced Plavix efficacy in patients who are poor metabolizers of Plavix.
February 11, 2010
The FDA has approved Benicar (olmesartan medoxomil tablets, from Daiichi Sankyo) for the treatment of hypertension in children and adolescents 6-16 years of age.
January 26, 2010
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted).
December 17, 2009
The FDA and The Medicines Company have notified healthcare professionals of a voluntary nationwide recall of 11 lots of Cleviprex (clevidipine butyrate) injection emulsion due to the presence of visible particulate matter observed in some vials.
December 07, 2009
Tris Pharma announced that the FDA has approved Clonidine ER suspension and Clonidine ER tablets, both of which utilize its proprietary OralXR+ platform technology to allow for once daily dosing.