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# PharmaTher Resubmits Ketamine NDA
- URL: https://www.fdaweb.com/pharmather-resubmits-ketamine-nda/
- Published: 2025-03-03T12:00:00.000Z
- Updated: 2026-09-14T14:54:24.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5158750

PharmaTher Holdings says it has resubmitted its NDA for Ketarx (ketamine) 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 submission is seeking the drug’s use in anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The company says it expected an FDA review action in the second quarter.

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.”