ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, announced that it has received a PDUFA (Prescription Drug User Fee Act) date of June 2, 2025, for its LipidRescue Kit. If approved, the kit will treat LAST with the rapid and accurate infusion of a clinically-recommended dose of lipid emulsion that has been shown to safely and effectively counteract toxicity and save patient lives. LAST is an uncommon but potentially fatal event that occurs during the use of local anesthetics.

The assignment of a PDUFA date is an important milestone for every new drug application as it indicates that the application is sufficiently complete to permit a substantive review and provides guidance on when the review should be completed.

Dr. Guy Weinberg, Founder and President of ResQ Pharma and the inventor of LipidRescue Therapy (LRT) said: "Since discovering more than 25 years ago that lipid emulsion infusion could reverse catastrophic reactions to local anesthetics, I have looked forward to the day that this novel therapy would become a widely available, standardized treatment for a dangerous and potentially fatal condition. As we await potential FDA review and approval, and prepare to launch the LipidRescue Kit, I'm very thankful to the many physicians, researchers, advisors and others who have been allies to ResQ Pharma over the years."  

Mukesh Kumar of FDAMap in Washington DC consulted on the preparation of the New Drug Application (NDA) for ResQ Pharma and serves as ResQ Pharma's Director of Regulatory Affairs. Michael Gaba, Vice Chair of Polsinelli's  FDA practice group, serves as ResQ Pharma's outside FDA counsel.