PharmaTher announces FDA acceptance of ANDA for KETARX

PharmaTher Holdings announced the U.S. Food and Drug Administration has accepted the Abbreviated New Drug Application for KETARX to the Food and Drug Administration. The FDA assigned a Generic Drug User Fee Amendments of 2022 goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine. PharmaTher’s priority is to commercialize KETARX in the U.S. through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.