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FDA Issues Second Complete Response Letter for PharmaTher's Ketamine ANDA

• The FDA issued a second Complete Response Letter (CRL) for PharmaTher's ketamine Abbreviated New Drug Application (ANDA) on October 22, 2024. • The FDA cited minor deficiencies related to drug substance, drug product, manufacturing, and microbiology in the CRL. • This CRL hinders efforts to increase ketamine availability in the US, where it has been in short supply since 2018. • PharmaTher plans to address the FDA's concerns and resubmit the ANDA as a minor amendment.

The FDA issued a Complete Response Letter (CRL) on October 22, 2024, regarding PharmaTher's Abbreviated New Drug Application (ANDA) for ketamine (KETARX). This second CRL follows an initial one issued on April 18, 2024, and pertains to the use of ketamine in anesthesia, sedation, pain management, mental health, and neurological indications.
PharmaTher indicated that the FDA classified the deficiencies noted in the CRL as minor, requesting updated information and clarifications on drug substance, drug product, manufacturing, and microbiology. The company stated, "The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology."
The FDA's decision impedes the broader availability of ketamine in the United States, where it has been officially listed as a scarce drug since February 2018. This shortage has led some patients to seek compounded ketamine products, including for mental health conditions for which it is not formally approved.

Concerns Regarding Compounded Ketamine

The FDA has previously raised concerns about the risks associated with compounded ketamine products, particularly those used for psychiatric disorders. On October 10, 2023, the agency issued a compounding risk alert, highlighting potential dangers linked to unapproved, in-home compounded ketamine administered via telehealth providers. Despite these concerns, a 2023 study showed that ketamine intravenous therapy significantly improved depression, anxiety, and suicidal ideation in real-world settings.

PharmaTher's Response

PharmaTher stated that the FDA did not express concerns regarding the stability of the ketamine submission batches, which have demonstrated stability for 18 months. Furthermore, the FDA did not request any new clinical trials.
"As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR," PharmaTher stated. The company plans to collaborate with its third-party manufacturing partner to address the identified deficiencies and respond to the FDA promptly.
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Reference News

[1]
FDA Issues CRL for Ketamine to Treat Pain, Mental Health, and More - HCPLive
hcplive.com · Oct 23, 2024

The FDA issued a CRL for PharmaTher's ketamine application, citing minor deficiencies in drug substance, product, manufa...

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