PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX™ (Ketamine) to the FDA
TORONTO, Sept. 06, 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 submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA. The Company anticipates KETARX™ approval 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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