PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug Application for Ketamine

TORONTO, May 10, 2024 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB:PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of an Amendment Acknowledgment Letter (“AAL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine from the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. As announced by the Company on April 18, 2024, the receipt of a Complete Response Letter (“CRL”), similar to the review letter FDA provided on possible deficiencies identified by Quality, as announced on February 12, 2024. There were no additional deficiencies mentioned in the CRL and AAL. The Company, demonstrating its commitment to quality and compliance, promptly completed the necessary tests and responses to address the FDA’s comments and submitted them to the FDA for their review, which resulted in the GDUFA goal date of October 29, 2024. The Company will provide updates as they occur.

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