Forest reports FDA approval for Bystolic

Forest Laboratories and Mylan have reported that the US Food and Drug Administration (FDA) has approved its beta blocker Bystolic in the treatment of hypertension.

The once-daily medication is already approved and marketed in 50 countries outside of North America but with the FDA decision Bystolic is expected to be available to physicians and patients in the US in January 2008.

Howard Solomon, chairman and chief executive of Forest, expressed the company’s delight in receiving FDA marketing approval for the beta blocker.

“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,” he added.

The FDA’s decision follows a series of clinical trials for Bystolic with the medication demonstrating significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive group of patients.

It was also found to be well tolerated with a low incidence of traditional beta blocker side effects.

Mylan first licensed the US and Canadian rights for Bystolic (nebivolol) from Janssen Pharmaceutica in 2001 with Forest licensing the same rights from Mylan in January 2006.

Last month, Forest and Lundbeck announced positive results for their Phase III study of Lexapro in adolescents with major depressive disorder.