PharmaTher says FDA extends review period for ketamine

PharmaTher (PHRRF) Holdings announced the U.S. Food and Drug Administration has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, 2025, revised from the previous date of June 4, 2025. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA’s Complete Response Letter dated October 22, 2024. “While we were prepared for a decision by June 4, 2025, we acknowledge the FDA’s need for additional time to review our recent submission and additional information request for the ketamine new drug application,” said Fabio Chianelli, CEO of PharmaTher. “We do not anticipate this extension to August 9, 2025, will materially impact our ongoing operational, business development, and commercialization initiatives for 2025.”