FDA issues approvable letter for Nebivolol for the treatment of hypertension

Forest Laboratories, Inc. and Mylan Inc. announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic), a novel beta blocker under review for the treatment of hypertension.

In the approvable letter the FDA indicated that a recent inspection of a backup manufacturing facility in Belgium uncovered deficiencies and that final marketing approval for nebivolol would be contingent upon satisfactory resolution of these deficiencies. The approvable letter did not raise any questions related to safety or efficacy of nebivolol. At this time, the companies and the FDA have agreed upon product labeling text.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a January 2008 launch meeting for Bystolic.

Robert J. Coury, Vice Chairman and CEO for Mylan, stated, "Bystolic (nebivolol) is a valuable asset to our organization and will be to the medical community and the patient population it will serve."

Howard Solomon, Chairman and Chief Executive Officer of Forest, stated: "We remain very encouraged by the prospects for nebivolol and anticipate that, following FDA marketing approval, nebivolol will be an important and welcome new option for physicians. We will work expeditiously with the FDA to secure final marketing approval."

Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. (currently Johnson & Johnson Pharmaceutical Research and Development) in 2001. Nebivolol is already registered and successfully marketed in more than 50 other countries outside of North America for the treatment of hypertension.

Forest licensed nebivolol from Mylan in January 2006 and has responsibility for all sales and marketing as well as current and future development programs. Mylan has retained an option to co-promote the product in the future.