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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).
The FDA's CRL requested new and updated information along with clarifications on the drug substance. Credit: freestocks on Unsplash.
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The CRL, dated 22 October 2024, comes ahead of the Generic Drug User Fee Amendments of 2022 (GDUFA) goal date set for 29 October 2024.
Ketamine, an essential medicine for anaesthesia and analgesia, is listed on the WHO Essential Medicines List and approved by Health Canada for use as a sedative and painkiller in hospitals.
Beyond these approved indications, ketamine is also administered to treat various neurological, mental health and pain disorders in hospitals and clinics.
The FDA’s CRL requested new and updated information along with clarifications on the drug substance, drug product, manufacturing, and microbiology aspects of the application.
However, the FDA did not raise concerns regarding the stability of the ketamine submission batches, which demonstrated 18-month stability without issue. Importantly, the FDA has not requested any new preclinical and clinical studies.
Ketamine has been listed on the drug shortage list of the FDA since February 2018, leading to an increase in the availability of compounded ketamine products not approved by the regulator for psychiatric disorders.
In October last year, the FDA published a compounding risk alert highlighting the potential risks associated with these ketamine products, especially those provided by telehealth services for in-home use.
The FDA has classified the required amendments to the application as minor, indicating that the resubmission will be considered a minor amendment.
Working with its third-party manufacturing partner, PharmaTher will address the deficiencies and respond to the FDA promptly.
The company intends to provide a timeline for its response to the FDA and continue to update on the progress.
