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Mylan's Nebivolol NDA User Fee Date Extended To May 31

This article was originally published in The Pink Sheet Daily

Executive Summary

Three-month delay means the beta blocker's user fee deadline will no longer coincide with the Feb. 28 "walk-away" date for Mylan's acquisition of King. Extension stems from recent submission "of an additional presentation of already submitted data from the nebivolol NDA," Mylan says.

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Mylan Seeks Licensing Partner, Heart Failure Indication For Nebivolol

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The beta blocker's user fee date had been extended by three months following submission of additional analysis. Mylan expects the anti-hypertensive to be the cornerstone of its brand division.

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