(RTTNews) - PharmaTher Holdings Ltd. (PHRM), on Wednesday, provided an update on its New Drug Application or NDA for ketamine, announcing plans to resubmit the necessary information to the FDA by the end of February 2025. This resubmission will address minor deficiencies outlined in the FDA's Complete Response Letter or CRL from October 2024.
PharmaTher anticipates receiving a new approval date for ketamine in the second quarter of 2025.
The deficiencies mentioned in the CRL are related to drug substance, drug product, manufacturing, and microbiology.
The FDA did not raise concerns about the stability of the ketamine batches, which showed 18 months of stability without issues, and no new preclinical or clinical studies were requested.
Ketamine has been a vital drug used for anesthesia and pain relief in hospitals, and outside of its FDA-approved uses, it is also administered off-label for various mental health and neurological disorders.
With its potential to treat unmet medical needs, PharmaTher is dedicated to making ketamine available globally and is committed to advancing its approval for a broad range of indications.
This milestone represents an important step for PharmaTher in fulfilling its mission to address critical gaps in patient care, and the company will continue to provide updates as they occur.
PHRRF is currently trading at $0.152 up by 8.57%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
