Posted by Michael Wonder on 13 Sep 2017
KemPharm announces FDRR process completion and resubmission of the Apadaz NDA
12 September 2017 - FDA has assigned a PDUFA action date of 23 February 2018.
KemPharm today announced completion of the Formal Dispute Resolution Request process with the U.S. FDA for Apadaz (benzhydrocodone and acetaminophen). Following detailed discussions with the FDA, KemPharm has responded to the complete response letter received on 13 June 2016 by submitting an amended new drug application for Apadaz.
The FDA has notified the Company with the determination that the application for Apadaz is complete and has assigned 23 February 2018 as the expected date by which an approval decision will be determined. Apadaz is KemPharm’s investigational product candidate that is intended to provide short-term management of acute pain.
