PharmaTher receives CRL from FDA for ketamine ANDA

PharmaTher (PHRRF) Holdings announced that the U.S. Food and Drug Administration has issued a complete response letter, dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 goal date of October 29, 2024. The deficiencies cited in the CRL are classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA 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. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The Company will be working with its third-party manufacturing partner to resolve these deficiencies and respond to the FDA in a timely fashion. The Company will provide a timeline for responding to the FDA as soon as possible and continue to provide updates as they occur.