Forest Labs/Mylan submit response to FDA "approvable" letter

Forest Laboratories says that its licensing partner, fellow USA-based Mylan Laboratories, has submitted a response to the "approvable" letter issued by the Food and Drug Administration for nebivolol, a selective beta 1-blocker with vasodilating properties, currently under US 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.

Forest licensed the agent 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. The drug is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America, the firms noted.