Forest, Mylan get FDA approvable letter for Nebivolol

NEW YORK Sun Dec 2, 2007 3:44pm EST

NEW YORK Dec 2 (Reuters) - Forest Laboratories Inc FRX.N and Mylan Inc MYL.N said on Sunday that both companies had received an approvable letter from the U.S. Food and Drug Administration for the hypertension drug Nebivolol.

The U.S. regulator indicated that a recent inspection of a backup manufacturing facility in Belgium uncovered deficiencies and that final marketing approval for Nebivolol would be condingent upon satisfactory resolution of these deficiencies.

The drug manufacturers said the approvable letter did not raise any questions related to the safety or efficacy of Nebivolol.

The companies expect to resolve the issue soon. And Forest continues to plan for a January 2008 launch meeting for the drug, which will be sold under the brand name Bystolic.

Nebivolol is already registered and marketed in more than 50 countries outside of North America for the treatment of hypertension. (Reporting by Euan Rocha; Editing by Jan Paschal)

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