Specialty biotech company PharmaTher Holdings (OTCQB: PHRRF) reported it has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, to the FDA. 

The company expects the agency will perform an expedited review of its ANDA, and anticipates KETARX’s approval and commercial launch in the U.S. in the second quarter of 2024. Following that, efforts for international approvals to support ketamine’s “growing global demand” will be made, PharmaTher stated. 

A developer and vendor of specialty pharmaceuticals with growing adoption and novel delivery methods for better patient outcomes, the company’s lead drug candidate KETARX aims …

Full story available on Benzinga.com

A note to our visitors

This website has updated its privacy policy in compliance with changes to European Union data protection law, for all members globally. We’ve also updated our Privacy Policy to give you more information about your rights and responsibilities with respect to your privacy and personal information. Please read this to review the updates about which cookies we use and what information we collect on our site. By continuing to use this site, you are agreeing to our updated privacy policy.