The FDA approved the use of Benicar (olmesartan medoxomil) for the treatment of hypertension in individuals aged 6 to 16 years. The drug original was cleared in 2002 for the treatment of adult hypertension.
Approval of the angiotensin-receptor blocker was based on a phase 3 study examining the antihypertensive effects of olmesartan in pediatric patients. The drug, which is marketed by Daiichi Sankyo, of Parsippany, N.J., was generally well tolerated and the adverse event profile was similar to that of adults.
About 3.6 million children in the United States have hypertension, the company noted.