PharmaTher Holdings Ltd., a specialty pharmaceutical company, has received an Amendment Acknowledgment Letter from the U.S. Food and Drug Administration for its Priority Original Abbreviated New Drug Application for Ketamine. The FDA has assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024. This follows the Company's announcement on April 18, 2024, regarding the receipt of a Complete Response Letter (CRL) related to quality concerns previously highlighted by the FDA on February 12, 2024. Importantly, no additional deficiencies were cited in the CRL and AAL.

In response, PharmaTher promptly conducted the necessary tests and submitted comprehensive responses to address the FDA's comments, resulting in the October 29, 2024, goal date. The Company remains dedicated to upholding quality standards and compliance.

PharmaTher's primary objective is to alleviate the ketamine shortage in the U.S. while ensuring adherence to FDA manufacturing guidelines and approved prescribing labels. Upon FDA approval and launch in the U.S., the Company intends to pursue international approvals to meet global ketamine demand. Long-term strategies involve exploring novel ketamine applications and delivery methods for potential pain, mental health, and neurological disorder treatments.

Ketamine scarcity has persisted since February 2018, leading to the proliferation of non-FDA-approved compounded ketamine products for psychiatric use. Recognizing the risks, the FDA issued a compounding risk alert on October 10, 2023, particularly cautioning against compounded ketamine products provided by telehealth services. These products lack FDA approval.

Ketamine, an essential medicine listed on the WHO Essential Medicines List, faces shortages in Canada and is approved for sedation and pain relief in hospital settings by Health Canada. Beyond approved indications, ketamine is increasingly used in hospitals and clinics to address various mental health, neurological, and pain conditions. Recent peer-reviewed studies underscore its real-world effectiveness in improving depression, anxiety, and suicidal ideation through intravenous therapy.

 

Source: globenewswire.com

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