- PharmaTher Holdings (CSE:PHRM) has revealed it has received an amendment acknowledgment letter for its priority original abbreviated New Drug Application for ketamine from the U.S. Food and Drug Administration
- The company has been assigned a goal date of Oct. 29, 2024
- PharmaTher aims to solve the ketamine shortage problem in the United States
- Shares of PharmaTher are down 21.67 per cent to C$0.23 as of 12:27 pm ET
PharmaTher Holdings (CSE:PHRM) has revealed it has received an amendment acknowledgment letter for its priority original abbreviated New Drug Application for ketamine from the U.S. Food and Drug Administration (FDA).
According to a statement, the company has been assigned a goal date of Oct. 29, 2024, as PharmaTher aims to solve the ketamine shortage problem in the United States.
The goal date comes after the company received a complete response letter similar to the review letter from the FDA, which indicated no additional deficiencies were found.
As such, the company continues to demonstrate its commitment to quality and compliance and aims to address the FDA’s comments and submit for review.
After the anticipated FDA approval and launch in the United States, PharmaTher intends to seek international approvals to support the global demand for ketamine.
Ketamine has been on the FDA’s drug shortage list since February 2018, which has likely contributed to the widespread availability of compounded ketamine products not FDA-approved for psychiatric disorders.
Ketamine is used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. The drug has been classified as a Tier 3 drug shortage in Canada since February 2023. Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings.
PharmaTher Holdings is focused on the development and commercialization of KETARX to meet unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications.
Shares of PharmaTher Holdings Ltd. (CSE:PHRM) are down 21.67 per cent to C$0.23 as of 12:27 pm ET.
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