11:09 AM EDT, 10/23/2024 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) , down 18% in morning trade, said the U.S. Food and Drug Administration (FDA) issued a complete response letter for the company's ketamine Abbreviated New Drug Application, identifying certain deficiencies which it classified as minor.

The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology, and 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 ) will be working with its third-party manufacturing partner to resolve these deficiencies and respond to the FDA in a timely fashion.

Ketamine has been on the FDA's drug shortage list since Feb. 2018.

The company's shares wee last seen down $0.05 to $0.23 on the Canadian Securities Exchange.

Price: 0.23, Change: -0.05, Percent Change: -18.18