PharmaTher Aims To Mitigate Ketamine Shortage With New FDA Application
Portfolio Pulse from Lara Goldstein
PharmaTher Holdings (OTCQB:PHRRF) has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, to the FDA. The company expects an expedited review and anticipates KETARX’s approval and commercial launch in the U.S. in Q2 2024. PharmaTher is also working on international approvals to meet the growing global demand for ketamine. The company is partnering with Vitruvias Therapeutics to commercialize KETARX in the U.S.
September 06, 2023 | 9:21 pm
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POSITIVE IMPACT
PharmaTher's submission of ANDA for KETARX to the FDA could potentially lead to its approval and commercial launch in the U.S. in Q2 2024. This could boost the company's revenues and market position.
The news of PharmaTher's ANDA submission for KETARX to the FDA is directly related to the company. If approved, this could lead to the commercial launch of KETARX in the U.S., potentially increasing the company's revenues and strengthening its market position. However, the approval process is uncertain and may take time.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100