Mylan has received an approvable from the U.S. Food and Drug Administration (FDA) for nebivolol (proposed brand name Bystolic(TM)), a novel beta blocker under review for the treatment of hypertension.
Forest Laboratories, and Mylan Inc. 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(TM)), a novel beta blocker under review for the treatment of hypertension. 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. 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. 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.
Forest Laboratories is a US-based pharmaceutical company product line includes Lexapro® (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda® (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; and Campral®* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical having direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.