PharmaTher Initiates Filing of Abbreviated New Drug Application for KETARX™ (racemic ketamine) to the FDA
TORONTO, June 27, 2023 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB:PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) to support expedited review of its priority ANDA. The filing of a Pre-Submission Facility Correspondence will help achieve approval early compared to the standard ANDA approval times. The Company anticipates KETARX™ approval from the FDA as early as Q1-2024 and commercial launch in the U.S. in Q2-2024 followed by the pursuit of international approvals to support the growing global demand for ketamine.
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