Bertek Submits NDA For Nebivolol; Beta Blocker Would Be Firm’s Third Branded Antihypertensive
This article was originally published in The Pink Sheet Daily
Executive Summary
The Mylan subsidiary claims patent protection into 2020 for nebivolol, a cardioselective beta blocker with vasodilating properties licensed from Janssen.
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Mylan's Nebivolol NDA User Fee Date Extended To May 31
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.
Mylan's Nebivolol NDA User Fee Date Extended To May 31
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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