Friday, April 19, 2024
PharmaTher Holdings Ltd. (PHRRF on OTCQB and PHRM on CSE), a specialized pharmaceutical firm, has received a Complete Response Letter (CRL) regarding its Priority Original Abbreviated New Drug Application (ANDA) for Ketamine from the U.S. Food and Drug Administration (FDA). The application was accepted and assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of April 29, 2024. The CRL mirrors the previous review letter issued by the FDA, highlighting Quality-related concerns disclosed on February 12, 2024, with no new deficiencies mentioned. The Company has addressed these issues by conducting necessary tests and formulating responses, which will be submitted to the FDA for further evaluation, leading to a revised GDUFA goal date. Updates will be provided accordingly.
Fabio Chianelli, CEO of PharmaTher, expressed optimism despite the delay, stating, "We are pleased that the FDA review of our ANDA has been completed without additional deficiencies. We have responded to the FDA's comments and are ensuring our responses accurately address their concerns. Our aim to obtain FDA approval for ketamine is progressing."
The Company's primary objective is to alleviate the ketamine shortage in the U.S. by adhering to FDA manufacturing guidelines and approved prescribing labels. Upon FDA approval and U.S. launch, international approvals will be pursued to meet global demand. Long-term strategies include exploring novel applications and delivery methods for ketamine in pain management, mental health, and neurological disorders.
Ketamine, an essential medicine listed on the WHO Essential Medicines List, has been experiencing shortages since February 2018 in the U.S. and since February 2023 in Canada. Health Canada has approved ketamine for sedation and pain relief in hospital settings. Despite being used off-label, ketamine has shown promising results in treating mental health disorders, as evidenced by recent peer-reviewed studies.
Source: globenewswire.com
