The FDA has approved Mylan Bertek Pharmaceuticals’ Bystolic (nebivolol) for the treatment of high blood pressure.
Bystolic is a beta blocker not previously approved in the United States, according to the FDA.
“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Douglas C. Throckmorton, MD, FDA's deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure,” Throckmorton said.
The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.
A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. The FDA reported that more than 2,000 people received Bystolic during the trials, and its efficacy during the trials was similar to those of other FDA-approved beta blockers.
The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea, according to the FDA report.
Forest Pharmaceuticals licensed the rights to sell Bystolic in the United States and Canada from the Canonsburg, Pa.-based Mylan in 2006. The New York City-based Forest said it will market Bystolic in the United States and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.