PharmaTher Provides Update on FDA Ketamine Application
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM), an innovative specialty pharmaceutical company, has some exciting news regarding its New Drug Application for Ketamine. The Company recently received positive feedback from the U.S. Food and Drug Administration (FDA), indicating that the review process is currently underway and that no additional information has been requested at this time.
Insights into the FDA Review Process
The FDA has established a goal date of October 29, 2024, under the Generic Drug User Fee Amendments of 2022 (GDUFA) for this application. This date represents a significant milestone, and PharmaTher is committed to keeping the public updated on any progress related to their application.
PharmaTher's Global Vision for Ketamine
Once FDA approval is granted, PharmaTher plans not only to launch ketamine in the U.S. market but also to extend its reach internationally. The Company is focused on obtaining approvals worldwide to meet the growing demand for ketamine as a treatment for various conditions, including Parkinson’s Disease. PharmaTher is eager to explore innovative applications and delivery methods for ketamine, concentrating on areas such as mental health and pain management.
The Role of Ketamine in Healthcare
One of PharmaTher's key goals is to address the ongoing ketamine shortage impacting the U.S. healthcare system, ensuring that their production meets the FDA’s stringent manufacturing standards. The importance of ketamine is significant; it has been an essential component of anesthetic procedures and pain management, earning its place on the World Health Organization's Essential Medicines List.
Market Challenges and Dynamics
Currently, ketamine has been listed on the FDA’s drug shortage inventory since early 2018, which has led to a rise in compounded ketamine alternatives that often lack FDA approval for psychiatric use. The FDA has raised concerns about the risks associated with these compounded products, issuing a compounding risk alert that highlights potential issues tied to unregulated alternatives.
About PharmaTher Holdings Ltd.
PharmaTher is committed to addressing unmet medical needs through the commercialization of its ketamine product, KETARX™. Additionally, the Company holds a 49% interest in Sairiyo Therapeutics Inc., which is advancing the development of innovative formulations for treating viral infections and other medical challenges.
Connect with PharmaTher
If you're interested in learning more about PharmaTher’s initiatives and upcoming projects, you can contact the company directly:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Frequently Asked Questions
What is the purpose of PharmaTher's NDA for Ketamine?
The NDA is intended to secure FDA approval for Ketamine, facilitating its use to effectively meet healthcare needs.
When is the FDA's GDUFA goal date for PharmaTher?
The FDA has set the GDUFA goal date for October 29, 2024, for the review of PharmaTher's application.
How does PharmaTher plan to commercialize Ketamine?
PharmaTher intends to launch Ketamine in the U.S. and seek international approvals to satisfy global demand, especially for treating Parkinson’s Disease.
What stake does PharmaTher have in Sairiyo Therapeutics Inc.?
PharmaTher owns a 49% stake in Sairiyo Therapeutics Inc., which focuses on developing innovative treatments for viral infectious diseases.
How can individuals obtain more information about PharmaTher?
Individuals can contact PharmaTher via phone or email, or visit their website for additional details about their products and services.
