Polsinelli serves as outside FDA counsel to ResQ Pharma, a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, and recently advised the company in successfully receiving a Prescription Drug User Fee Act (PDUFA) date of June 2, 2025, for its groundbreaking LipidRescue Kit.

If approved, the kit will treat Local Anesthetic Systemic Toxicity (LAST) with a rapid and accurate infusion of a clinically recommended dose of lipid emulsion to safely and effectively counteract toxicity and save patient lives. LAST is a rare, but life-threatening event that can occur when local anesthetics are used in any variety of healthcare settings.

Assigning a PDUFA date marks a critical milestone for every new drug application, signifying that the application is comprehensive enough to undergo a substantive review and provides a timeline for when the review process should be completed.

More information about ResQ Pharma’s PDUFA date and their LipidRescue Kit can be found here.

Food and Drug Practice Vice Chair Michael M. Gaba and FDA Associate Suzanne E. Bassett counseled ResQ Pharma in this matter.