FDA Actions

FDA Actions

The FDA has approved the first generic version of donepezil (Aricept^®) for the treatment of Alzheimer's disease. The new generic will be marketed as 5 mg and 10 mg orally disintegrating tablets, which dissolve on the tongue and do not need to be swallowed. Generic donepezil is expected to be available later this year.

An FDA advisory panel is recommending expansion of the indication for rosuvastatin (Crestor^®) to include patients with normal cholesterol levels and no history of cardiovascular disease. The recommendation is based on the JUPITER trial, which showed a reduction in cardiovascular risk in patients with normal LDL cholesterol but high C-reactive protein who were treated with rosuvastatin.