PharmaTher receives GDUFA goal date of October 29 for ketamine NDA

PharmaTher Holdings announced an update for its New Drug Application for Ketamine from the U.S. Food and Drug Administration with an assigned a Generic Drug User Fee Amendments of 2022 goal date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and no additional information is needed, but is subject to change. The Company will continue to provide updates as they occur. 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 and its commercial development strategy to treat Parkinson’s Disease. In addition, the Company will pursue novel uses and delivery methods of ketamine for mental health, pain, neurological and medical countermeasures indications. 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. Ketamine has been on the FDA’s drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded ketamine products not FDA approved for psychiatric disorders. On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded ketamine products for psychiatric disorders, specifically from telehealth providers that provide in-home ketamine services. These compounded ketamine products are not FDA approved