The US FDA issued a CRL to PharmaTher for deficiencies in their application for racemic ketamine. The FDA requested new information related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches. PharmaTher plans to work with their manufacturing partner to resolve the deficiencies. Ketamine is approved for anesthesia and analgesia, but not for psychiatric disorders. Compounded ketamine products have been marketed for psychiatric disorders, leading to FDA concerns about safety. FDA received reports of adverse events related to compounded ketamine, prompting warnings about at-home use. PharmaTher is committed to solving the ketamine shortage issue and following FDA guidelines.
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FDA Requests More Info on PharmaTher’s Ketamine Application
