PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARX™ (Ketamine) On-Body Pump System
TORONTO, Feb. 07, 2023 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB:PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its Type B meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss the remaining requirements for the KETARX™ On-Body Pump System (subcutaneous racemic ketamine) and submission of a New Drug Application (“NDA”) under the 505(b)(2) pathway. PharmaTher aims to leverage its own CMC information, clinical data and available non-clinical and clinical data to submit an NDA by the end of 2023. The meeting date with the FDA is set for March 23, 2023.
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