PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB:PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024. As announced by the Company on February 12, 2024, the ANDA is under priority review by the FDA and has been provided with preliminary thoughts on possible deficiencies identified by the Quality reviewers. The Company has completed the necessary tests and responses to address the FDA’s comments. The Company aims to submit its responses to the FDA by the end of this week. There can be no assurance the GDUFA goal date will be met. Should the goal date not be met, the FDA would provide a Complete Response Letter to the Company to address the responses, provide additional feedback, if any, and assign an appropriate goal date. The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.

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