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PharmaTher Receives FDA Priority Designation for Abbreviated New Drug Application of KETARX™ (Ketamine)

Thursday, September 28, 2023

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM), a specialized pharmaceutical company with a focus on commercialization, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for KETARX™, a racemic ketamine formulation. The FDA has set an April 29, 2024 goal date for the Generic Drug User Fee Amendments of 2022 (GDUFA) for this priority original ANDA. Following FDA approval, the company intends to launch KETARX™ in the United States and seek international approvals to meet the growing global demand for ketamine.

Fabio Chianelli, CEO of PharmaTher, emphasized the significance of this achievement, stating, The acceptance of the ANDA for ketamine is a pivotal milestone for PharmaTher, bringing us closer to becoming a global leader in ketamine for addressing unmet medical needs. Ketamine has been listed on the FDA's drug shortage inventory for over five years, and its potential in treating mental health, neurological, and pain disorders continues to gain recognition through published clinical research and real-world applications.

Ketamine is an essential medication used for anesthesia and pain relief, featured on the WHO Essential Medicines List. It has faced shortages on both the FDA and Health Canada lists since February 2018 and February 2023, respectively. Beyond its approved indications, ketamine is also administered in healthcare settings to address various mental health, neurological, and pain disorders. Recent peer-reviewed studies have highlighted its effectiveness in improving conditions such as depression, anxiety, and suicidal ideation when administered intravenously.

PharmaTher's primary goal is to commercialize KETARX™ in the U.S. through a partnership with Vitruvias Therapeutics, Inc., a prominent U.S.-based specialty generic pharmaceutical company. The company intends to offer various KETARX™ dosage forms and explore opportunities to enhance concentration and ready-to-administer applications for both U.S. and international markets.

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