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).
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).
January 11, 2010
Amarin Corporation announced the enrollment of patients in their two Phase 3 trials of AMR101 for the treatment of patients with high triglycerides.
November 16, 2009
Aegerion Pharmaceuticals announced additional data from its ongoing Phase 3 trial involving lomitapide (AEGR-733) for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH), a rare and extremely serious condition resulting in severely elevated levels of low-density lipoprotein cholesterol (LDL-C).
November 13, 2009
The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of certain lots of Cerezyme (imiglucerase), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alpha), Aldurazyme (laronidase), and Thyrogen (thyrotropin alpha).