The Food and Durg Administration (FDA) has accepted specialty biopharma company PharmaTher Holdings' (OTCQB:PHRRF) new drug application for a racemic ketamine product.
What Happened: The so-called goal date for PharmaTher's KETARX drug is April 29, 2024, according to the FDA.
From the Abbreviated New Drug Application (ANDA) acceptance phase, PharmaTher anticipates KETARX's U.S. commercial launch and the pursuit of international approvals thereafter.
The ANDA acceptance is a significant milestone for PharmaTher, according to CEO Fabio Chianelli.
The move brings PharmaTher "one step closer to becoming a global leader in ketamine for unmet medical needs," especially considering the compound "has been on the FDA's drug shortage list for over [five] years, and its potential for mental health, neurological, and pain disorders continues to gain momentum and validation through published clinical research and real-world use cases."
See Also: PsychMD's Nationwide, Safe-Supplied AI-Driven Ketamine Therapy With US Vets In Mind
Why It Matters: Ketamine is used for anesthesia and analgesia, and is listed on the WHO Essential Medicines List. Outside the FDA and Health Canada approved indications, it is also being administered in hospitals and clinics to treat mental health, neurological and pain disorders.
PharmaTher's priority is to commercialize KETARX in several dosage forms, with the option to increase concentration and ready-to-administer applications, in the U.S. through its partnership with specialty generic pharmaceutical company Vitruvias Therapeutics.
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Photo: Benzinga edit with photo by qimono on Pixabay and Doc James on Wikimedia Commons.