US FDA approves Forest, Mylan blood pressure drug
(Adds details from FDA statement, background)
WASHINGTON, Dec 17 (Reuters) - U.S. health officials said on Monday they approved sales of a new blood pressure drug from Mylan Inc MYL.N called nebivolol.
Forest Laboratories Inc (FRX.N) will market the prescription drug under the name Bystolic, a Food and Drug Administration statement said.
Nearly one in three U.S. adults has high blood pressure, which can raise the risk of a stroke, heart failure, heart attack, kidney failure and death.
Bystolic is a new member of the class of drugs known as beta blockers, which lower blood pressure by reducing the force with which the heart pumps.
More than 2,000 people received Bystolic during clinical trials. The drug's efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.
On Dec. 2, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.
