FDA approves Allergan’s Byvalson

SILVER SPRING, Md. — The Food and Drug Administration has approved Allergan’s Byvalson (nebivolol 5 mg and valsartan 80 mg) tablets, the company announced Monday. The drug is indicated to treat hypertension to lower blood pressure, and the company said it is the first fixed-dose combination of a beta-blocker and an angiotensin II receptor blocker in the U.S. 

 

“Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events,” Allergan chief R&D officer David Nicholson said. “There remains a need for new therapies, as observed by the nearly half of patients in the U.S. who remain uncontrolled. We are pleased with the FDA approval of Byvalson, which will provide physicians a new fixed-dose combination therapy treatment option for patients affected by hypertension.”

 

Allergan expects Byvalson to be available in the second half of 2016.