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Mylan nebivolol “approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Mylan's beta blocker nebivolol is "approvable" May 31 for treatment of hypertension. "Final approval of nebivolol is contingent upon successfully satisfying additional FDA requirements regarding certain aspects of the preclinical data and finalization of the labeling," Mylan said. The company is conducting a preclinical study, expected to be complete by year end, which it believes will answer FDA's questions. The agency extended nebivolol's initial user fee deadline of Feb. 28 by 90 days following the sponsor's submission of an "additional presentation of already submitted data" (1Pharmaceutical Approvals Monthly March 2005, p. 8). Mylan announced during a June 14 conference call that it is also targeting a congestive heart failure claim for nebivolol and expects to have a licensing partner by fall...

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