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PharmaTher Says FDA Extends Ketamine Review Period to Aug 9
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PharmaTher Says FDA Extends Ketamine Review Period to Aug 9
May 26, 2025 9:29 AM

08:19 AM EDT, 05/16/2025 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) on Friday said the U.S. Food and Drug Administration (FDA) has extended the approval goal date for the review of its new drug application for ketamine, to Aug. 9 from June 4.

PharmaTher ( PHRRF ) confirms it has previously addressed all issues raised in the FDA's Complete Response Letter dated Oct. 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, chief executive. "We do not anticipate this extension to August 9, 2025, will materially impact our ongoing operational, business development, and commercialization initiatives for 2025."

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