FDA OKs PharmaTher’s Ketamine for Surgical Pain

FDA has approved PharmaTher’s KETARx (ketamine), indicated for use in treating surgical pain. The company says the approval of KETARx “provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the company's product pipeline.” It says. Tthese include mental health conditions like depression, neurological disorders such as Parkinson's disease and amyotrophic lateral sclerosis and managing rare or chronic pain, including complex regional pain syndrome. 

Since 2/2018, ketamine has been regularly listed on FDA’s drug shortage list, which indicates a serious need for consistent, high-quality supply, PharmaTher says. “This issue is cautioned by a compounding risk alert issued by the FDA on 10/10/2023, which detailed potential risks associated with compounded ketamine products used for psychiatric disorders,” it adds.