PharmaTher Receives New Early June FDA Goal Date for Ketamine

Published on: March 11, 2025

With a new FDA goal date in June, ketamine is one step closer to receiving approval for anesthesia, sedation, pain, mental health, and neurological indications.

PharmaTher announced today, March 11, 2025, that the company received a new US Food and Drug Administration (FDA) goal date for ketamine to treat anesthesia, sedation, pain, mental health, and neurological indications: June 4, 2025.1,2

“I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine drug,” said Fabio Chianelli, chairman and CEO of PharmaTher, in a statement.1 “We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to fill the demand gap in the U.S. market.”

This news arrived in the form of an Amendment Acknowledgment Letter (AAL) from the FDA. Following a complete response letter (CRL) back in October 2024 that stated minor deficiencies, PharmaTher announced their resubmission to the complete response amendment on March 3, 2025.2

In the CRL, the FDA requested updated information on drug substances, drug products, manufacturing, and microbiology. They did not express concern about the stability of the Ketamine submission batches nor request new preclinical or clinical trials. The AAL did not note any additional deficiencies.1

PharmaTher hopes to address the ketamine shortage in the US. Ketamine, used to treat anesthesia, analgesia, neurological disorders, and mental health, can significantly impact patients’ lives.

Ketamine has sat on the FDA’s drug shortage list since February 2018, and this scarcity may have prompted individuals to seek out compounded ketamine products. Thus, the shortage of ketamine could explain the current widespread availability of compounded Ketamine products that have questionable safety.

The FDA published a compounding risk alert on October 10, 2023, warning about the potential risks of compounded ketamine products for psychiatric disorders. These risks were discovered among patients receiving in-home compounded ketamine for mental health, an unapproved indication, via telehealth providers.

If ketamine does expand in availability, PharmaTher states it may parallel what recently happened when Wegovy and Ozempic were removed from the FDA drug shortage list: a 60- to 90-day grace period for compounders to stop supplying these drugs.

References

PharmaTher Receives US FDA Approval Goal Date for Ketamine. Globe Newswire. March 11, 2025. https://www.globenewswire.com/news-release/2025/03/11/3040486/0/en/PharmaTher-Receives-US-FDA-Approval-Goal-Date-for-Ketamine.html. Accessed March 11, 2025.
Derman, C. FDA Issues CRL for Ketamine to Treat Pain, Mental Health, and More. HCPLive. October 23, 2024. https://www.hcplive.com/view/fda-issues-crl-ketamine-treat-pain-mental-health-more. Accessed March 11, 2025.

PharmaTher Receives New Early June FDA Goal Date for Ketamine

PharmaTher Receives US FDA Approval Goal Date for Ketamine. Globe Newswire. March 11, 2025. https://www.globenewswire.com/news-release/2025/03/11/3040486/0/en/PharmaTher-Receives-US-FDA-Approval-Goal-Date-for-Ketamine.html. Accessed March 11, 2025.

Derman, C. FDA Issues CRL for Ketamine to Treat Pain, Mental Health, and More. HCPLive. October 23, 2024. https://www.hcplive.com/view/fda-issues-crl-ketamine-treat-pain-mental-health-more. Accessed March 11, 2025.