08:56 AM EST, 02/12/2025 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) on Wednesday said it is on track to resubmit information to the Food & Drug Administration by the end of this month for ketamine.

The resubmission addresses the deficiencies that were classified as "minor" in the October complete response letter by the FDA. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The agency did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

PharmaTher ( PHRRF ) expects to receive a new date for a second quarter FDA approval