PharmaTher provides update on priority original ANDA for ketamine

PharmaTher Holdings provides an update of its Priority Original Abbreviated New Drug Application for Ketamine that was accepted by the U.S. Food and Drug Administration and assigned a Generic Drug User Fee Amendments of 2022 goal date of April 29, 2024. As announced by the Company on February 12, 2024, the ANDA is under priority review by the FDA and has been provided with preliminary thoughts on possible deficiencies identified by the Quality reviewers. The Company has completed the necessary tests and responses to address the FDA’s comments. The Company aims to submit its responses to the FDA by the end of this week. There can be no assurance the GDUFA goal date will be met. Should the goal date not be met, the FDA would provide a Complete Response Letter to the Company to address the responses, provide additional feedback, if any, and assign an appropriate goal date. The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur. The Company’s overall goal is to solve the ketamine shortage problem in the U.S. and its ketamine to adhere to the FDA’s strict manufacturing guidelines and FDA-approved prescribing label. Following the anticipated FDA approval and launch in the U.S., the Company aims to pursue international approvals to support the global demand for ketamine. The Company’s long-term strategy is pursuing novel uses and delivery methods of ketamine as a potential treatment for pain, mental health, and neurological disorders.