PharmaTher Holdings Ltd. announced the U.S. Food and Drug Administration has accepted the Abbreviated New Drug Application (?ANDA?) for KETARX? (racemic ketamine) to the Food and Drug Administration (?FDA?). The FDA assigned a Generic Drug User Fee Amendments of 2022 (?GDUFA?) goal date for this priority original ANDA of April 29, 2024.

The Company anticipates the commercial launch of KETARX? in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine. Ketamine is an essential medicine used for anaesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List.

Ketamine has been on the FDA?s drug shortage list since February 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders.

A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.