08:39 AM EDT, 04/16/2024 (MT Newswires) -- PharmaTher Holdings Ltd. ( PHRRF ) , a specialty pharmaceutical company, on Tuesday provided an update on its Priority Original Abbreviated New Drug Application (ANDA) for Ketamine that was accepted by the Food and Drug Administration (FDA) and assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of April 29, 2024.

As was previously announced, the ANDA is under priority review by the FDA and PharmaTher ( PHRRF ) has been provided with preliminary thoughts on possible deficiencies identified by the Quality reviewers. The company said it has completed the tests and responses to address the FDA's comments, and aims to submit its responses to the agency by the end of this week.

There can be no assurance the GDUFA goal date will be met, PharmaTher ( PHRRF ) cautioned. If not met, the FDA would provide a Complete Response Letter to address the responses, provide additional feedback, if any, and assign an appropriate goal date. PharmaTer added it is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.

Ketamine, used for anesthesia and analgesia (pain relief), has been on the FDA's drug shortage list since February 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023.