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news.Mylan has received an approvable letter from the FDA in response to its new drug application for nebivolol, proposed brand name Bystolic, a novel beta blocker under review for the treatment of hypertension.
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The FDA has 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.
Both Mylan and its partner Forest Laboratories anticipate an expeditious resolution to this issue, and Forest continues to plan for a January 2008 launch meeting for Bystolic.
Howard Solomon, chairman and CEO of Forest, said: “We will work expeditiously with the FDA to secure final marketing approval.”