FDA News

Response Submitted To FDA Approvable Letter For Hypertension Compound Nebivolol

(May 2, 2007)-- Forest Laboratories, announced that its licensing partner Mylan Laboratories submitted a response to the approvable letter issued by the United States Food and Drug Administration (FDA) for the compound nebivolol, a selective beta 1- blocker with vasodilating properties currently under U.S. regulatory review for the treatment of hypertension. Upon acceptance of this response, Forest anticipates the FDA will complete its review of nebivolol's new drug application within six months.

"We believe the supplemental data will provide the FDA with the information they have requested. Nebivolol has already received an approvable letter and we are confident that it should soon be approved. We expect that nebivolol will provide an important new option for physicians in the management of hypertension," said Howard Solomon, Chairman and Chief Executive Officer, Forest Laboratories. "We are excited about the opportunity to market nebivolol and look forward to a long-term collaboration with Mylan."

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

"In partnership with Forest Laboratories, we have secured the data required by the FDA in the approvable letter for nebivolol," said Robert J. Coury, Vice Chairman and Chief Executive Officer of Mylan Laboratories. "We continue to be committed to providing the necessary support for nebivolol to gain approval in the U.S."

Nebivolol is a selective beta 1-adrenergic (cardioselective) receptor antagonist with vasodilating properties and is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America.

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