Mon. 4 Mar 2024, 7:33am ET
Benzinga
News, FDA
In addition, the FDA has set a new Prescription Drug User Fee Act ("PDUFA") action date of September 21, 2024, and has re-affirmed its intent to present the resubmission for discussion at an advisory committee meeting to be scheduled. As part of the ongoing review, Zevra received notification from the FDA that it required more time to review the additional analyses provided by the Company in responses to recent information requests generated from the FDA's review.