Forest Laboratories Inc. (NYSE:FRX) and Mylan Inc.(NYSE:MYL) have received U.S. Food and Drug Administration approval for their beta blocker Bystolic.
Bystolic, indicated for the treatment of hypertension, is a one daily medication that can be used in conjunction with other high blood pressure drugs or alone. The drug is a beta blocker which is one of the most prescribed classes of drug in the U.S. In several clinical trials Bystolic showed significant decreases in sitting diastolic and systolic blood pressure in a group of patients that included 26 percent black, 54 percent male, 19 percent elderly and 8 percent diabetic.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."
Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic was found to be well tolerated with minimal incidence of traditional beta blocker side effects. The drug decreases heart rate and myocardial contractility and suppresses renin activity. Bystolic is already approved and marketed in more than 50 countries worldwide.
The most common side effects of Bystolic were headache, dizziness and fatigue. Patients are advised against abrupt discontinuation of the drug and those with severe bradycardia, cardiogenic shock, decompensated cardiac failure, severe hepatic impairment, peripheral vascular disease and severe renal impairment are cautioned or contraindicated from using the drug.
[Source: PRNewsWire]
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