Posted by Michael Wonder on 24 Jan 2023
Fabre-Kramer Pharmaceuticals announces FDA acceptance of NDA resubmission as complete response and assignment of PDUFA regulatory action date
24 January 2023 - Submission of Exxua (gepirone hydrochloride), a novel targeted single serotonin receptor agonist for treatment of major depressive disorder receives PDUFA action date of 23 June 2023.
Fabre-Kramer Pharmaceuticals announced today it received on 20 January 2023 acknowledgement and acceptance of its 23 December 2022 new drug application amendment for Exxua (gepirone hydrochloride) extended release tablets for the treatment of major depressive disorder.
