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Forest Laboratories Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that the U.S. Food and Drug Administration has approved the novel beta blocker Bystolic for the treatment of high blood pressure.

Bystolic is a once a day drug that can be used alone or in combination with other hypertension medications in the treatment of high blood pressure. An extensive clinical trial that involved more than 2000 patients, Bystolic showed significant decreases in sitting diastolic and systolic blood pressure. The medication was found to be well tolerated with low incidence of normal beta blocker side effects.

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."

The medication has already been marketed and sold in more than 50 countries outside of North America and Forest Laboratories expected Bystolic to be available in January 2008.

As with other medications, Bystolic should not be stopped abruptly. When stopping the medication, dosage should be reduced gradually over a one to two week time frame and the patient should be closely monitored as severe exacerbation of angina and occurrences of myocardial infarctions have been reported after abrupt cessation of therapy.

Caution is indicated for patients with peripheral vascular disease, thyrotoxisis, severe renal impairment or hepatic impairment. Beta blockers can mask some manifestation of hypogylcemia therefore diabetic patients could be cautious.

[Source: PRNewsWire]