PharmaTher Holdings announced it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application for KETARX to the Food and Drug Administration 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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