PharmaTher: FDA provides preliminary thoughts on possible deficiencies for ANDA

PharmaTher Holdings provides an update of its Priority Original Abbreviated New Drug Applicatio 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. The ANDA continues to be under review by the FDA and has provided preliminary thoughts on possible deficiencies identified by Quality. The Company aims to respond to satisfy the preliminary thoughts on possible deficiencies before the goal date. The Company received a waiver from the FDA for bioequivalence studies and has not identified any deficiencies. There can be no assurance the goal date will be met. The FDA may assign an appropriate goal date. The Company will provide updates 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.