PharmaTher says FDA grants post-complete letter clarification meeting

PharmaTher (PHRRF) announced that the FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024. As previously announced, the Company requested the Meeting in response to the FDA issuing 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 Company has initiated activities to address the deficiencies cited in the CRL. 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 announce a proposed timeline for the resubmission to this CRL after the Meeting and continue to provide updates as they occur.