FDA update on brand drugs for February 11, 2010

[chantell.reagan]

Expanded indications/labeling changes:

Crestor (rosuvastatin) by AstraZeneca
Expanded indication: to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease. (The FDA approval was based on data from the JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin)

•Link to AZ press release 2/10
•Link to prescribing information

Lamictal XR (lamotrigine) by GlaxoSmithKline
Expanded indication: once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. (This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients in this age group).

•Link to GSK press release 1/10

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER