PharmaTher Provides Exciting FDA Update on Ketamine Application
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PharmaTher Updates on FDA Ketamine Application Progress
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM), a pioneering specialty pharmaceutical entity, has exciting developments to share regarding its New Drug Application for Ketamine. Recently, the Company received favorable feedback from the U.S. Food and Drug Administration (FDA), noting that the review process is currently in motion with no requested additional information as of now.
Understanding the FDA Review Process
The FDA has set a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024, for this application. This timeline is a critical milestone, and PharmaTher is dedicated to keeping the public informed with any advances regarding their application.
Global Aspirations for Ketamine
Following the expected FDA approval, PharmaTher aims to not only introduce ketamine into the U.S. market but also seeks to expand its reach globally. Their strategy encompasses pursuing international approvals to cater to the rising demand for ketamine as a treatment for various conditions, including Parkinson’s Disease. PharmaTher is passionate about exploring novel applications and delivery methods of ketamine, focusing on diverse fields such as mental health and pain management.
The Importance of Ketamine in Healthcare
One of PharmaTher's primary objectives is to tackle the ketamine shortage affecting the U.S. healthcare system, ensuring that their ketamine production aligns with the FDA’s rigorous manufacturing protocols. The significance of ketamine cannot be understated; it has been a vital part of anesthetic procedures and pain relief, securing its position on the World Health Organization's Essential Medicines List.
Challenges and Market Dynamics
As of now, ketamine has been listed on the FDA’s drug shortage inventory since early 2018, fostering an environment for compounded ketamine alternatives, which often lack FDA approval for psychiatric applications. The subsequent risks related to compounded products have been highlighted by the FDA, as they issued a compounding risk alert mentioning potential issues associated with such unregulated products.
Overview of PharmaTher Holdings Ltd.
PharmaTher is dedicated to addressing unmet medical needs through the commercialization of their ketamine product, KETARX™. The Company also holds a 49% stake in Sairiyo Therapeutics Inc., which is making strides in developing innovative formulations for treating viral infections among other medical countermeasures.
Get Connected with PharmaTher
For those interested in learning more about PharmaTher’s initiatives and future developments, the company can be reached 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 aims to seek FDA approval for Ketamine, allowing its use to address healthcare needs effectively.
When is the FDA's GDUFA goal date set 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 plans to launch Ketamine in the U.S. and pursue international approvals to meet global demand, particularly in treating Parkinson’s Disease.
What is PharmaTher's stake in Sairiyo Therapeutics Inc.?
PharmaTher owns 49% of Sairiyo Therapeutics Inc., focusing on developing novel treatments for viral infectious diseases.
How can individuals get more information about PharmaTher?
Individuals can reach PharmaTher by phone or email, or visit their website for more details on their products and services.
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