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# PharmaTher Ketamine NDA Review Extended by FDA
- URL: https://www.fdaweb.com/pharmather-ketamine-nda-review-extended-by-fda/
- Published: 2025-05-16T12:00:00.000Z
- Updated: 2026-09-14T15:12:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159195

FDA has extended by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The extension allows the agency more time to review information requests, which it has classified as a minor amendment, according to the company.

The NDA was resubmitted in March to address “minor” deficiencies cited in a 10/22/2024 complete response letter ([see earlier story](https://www.fdaweb.com/pharmather-complete-response-letter-on-ketamine/)). The company previously reported that the complete response letter requested new and updated information and clarifications related to drug substance, drug product, manufacturing and microbiology, adding that it did not “express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.”

FDA has told the company that the new user fee review action target date is 8/9.