Chicago-based pharmaceutical company ResQ Pharma Inc announced on Monday that it has received a PDUFA (Prescription Drug User Fee Act) date of 2 June 2025, for its LipidRescue Kit.
If the kit receives approval, it will be used to treat Local Anesthetic Systemic Toxicity (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 anaesthetics.
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 anaesthetics, I have looked forward to the day that this novel therapy would become a widely available, standardised 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."
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
NeuroSense reveals strategy to advance PrimeC toward potential ALS approval
UCB agrees with US government to lower medicine costs and strengthen US manufacturing
Karyopharm seeks accelerated FDA approval for selinexor–ruxolitinib in myelofibrosis