08:41 AM EST, 11/13/2024 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) , a specialty pharmaceutical company, on Wednesday said the Food & Drug Administration (FDA) agreed to meet with the company to clarify certain issues in the agency's complete response letter to the company.

The company had previously requested a post-complete letter clarification meeting with the FDA, which had been granted for Nov. 29. PharmaTher ( PHRRF ) asked for it to be rescheduled by a week, due to the Thanksgiving holiday.

A new date hasn't been fixed yet.

The company was assigned a Generic Drug User Fee Amendments (GDUFA) goal date of October 29, 2024 for its ketamine application. Ketamine has been on the FDA's drug shortage list since early 2018.