2nd Oct 2015 07:39
LONDON (Alliance News) - Biopharmaceutical company Biofrontera AG on Friday said it has received a 74-day letter from the US Food and Drug Administration regarding the approval process for its Ameluz skin cancer treatment.
Its its filing review, the US regulator did not identify any potential issues with Ameluz and has set the day of the approval letter at May 10, 2016, meaning it intends to use two months less than in most drug approvals for its review process.
"The choice of 10 May 2016 as PDUFA date is great news. FDA has not made use of their maximum 12-month review period, thereby potentially reducing time-to-market by two months," said Hermann Luebbert, Biofrontera's chief executive.
Shares in Biofrontera were untraded Friday morning, having last traded at 195.50 pence.
By Sam Unsted; [email protected]; @SamUAtAlliance
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