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Press Release - November 2024
FDA Accepts NDA for LipidRescue™ with PDUFA Date Set for June 2025 – Regulatory Milestone Achieved with FDAMap Clinical’s Expert Guidance Gaithersburg, MD - November 13, 2024 FDAMap Clinical is thrilled to announce the successful submission of ResQ Pharma’s NDA for LipidRescue™, a critical care treatment for Local Anesthetic Systemic Toxicity (LAST). The FDA has set a PDUFA date of June 2, 2025, for this application. The FDA’s decision to accept for review the LipidRescue™ NDA is a monumental leap forward in ensuring that every healthcare provider will soon be equipped with a treatment that is as vital as a first aid kit to treat LAST, a proverbial “fire extinguisher” for when a person begins to experience LAST. Once approved, Lipid Rescue™ will be an essential item in every medical facility nationwide, poised to make a multi-billion-dollar impact across the healthcare industry. |
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Dr. Guy Weinberg, the visionary behind LipidRescue™ and a Professor of Anesthesiology at the University of Illinois College of Medicine, discovered the power of lipid infusion therapy in 1998. His groundbreaking research has already saved lives by reversing cardiac and neurological toxicity caused by local anesthetics and other fat-soluble agents. Now, with the FDA’s review process officially underway, LipidRescue™ is on the verge of becoming an indispensable tool in emergency care.
As stated by Dr. Weinberg, “The filing is a huge milestone for ResQ Pharma. In the pharma world, having a PDUFA date is a big deal, and in the FDA’s own words, it indicates our application is ‘. . . sufficiently complete to permit a substantive review’.” Special thanks go to Mukesh and his team at FDAMap who put in hours of yeoman’s work helping to prepare and organize the NDA.”
The expert team at FDAMap, led by Dr. Mukesh Kumar, was instrumental in guiding ResQ Pharma through the complex regulatory process. Their strategic oversight ensured that the LipidRescue™ submission met all FDA safety and efficacy standards.
"This is the first product of its kind developed in the U.S., and it’s set to be a game changer for patient safety during routine surgeries involving local anesthetics. We’re thrilled about the potential impact LipidRescue™ can have in enhancing patient outcomes and providing an essential safety net in clinical settings," says Dr. Kumar.
ResQ Pharma will provide further updates to investors and stakeholders during Q1 2025 as the company continues to work toward final FDA approval and commercialization.
About FDAMap Clinical
FDAMap Clinical is a full-service Contract Research Organization (CRO) offering expert regulatory, clinical trial management, and strategic guidance for biopharma and medical device companies. Led by Dr. Mukesh Kumar, FDAMap Clinical has a strong track record of bringing life-saving treatments like LipidRescue™ through the FDA approval process and into the hands of healthcare professionals.
The future of emergency care is here, and with the FDA’s acceptance of the LipidRescue™ NDA and the PDUFA date set, ResQ Pharma and FDAMap Clinical are paving the way for a new era in life-saving medical tools. Stay tuned for updates as this revolutionary treatment moves toward approval!
Stay informed on the latest developments by following FDAMap Clinical on LinkedIn and subscribing to our newsletter for ongoing updates on this and other groundbreaking projects at www.fdamapclinical.com or contact us directly.
Media Contact:
Rachel Greiner
Director of Business Development
FDAMap Clinical
Phone: 1-877-566-4981
Email: [email protected]
As stated by Dr. Weinberg, “The filing is a huge milestone for ResQ Pharma. In the pharma world, having a PDUFA date is a big deal, and in the FDA’s own words, it indicates our application is ‘. . . sufficiently complete to permit a substantive review’.” Special thanks go to Mukesh and his team at FDAMap who put in hours of yeoman’s work helping to prepare and organize the NDA.”
The expert team at FDAMap, led by Dr. Mukesh Kumar, was instrumental in guiding ResQ Pharma through the complex regulatory process. Their strategic oversight ensured that the LipidRescue™ submission met all FDA safety and efficacy standards.
"This is the first product of its kind developed in the U.S., and it’s set to be a game changer for patient safety during routine surgeries involving local anesthetics. We’re thrilled about the potential impact LipidRescue™ can have in enhancing patient outcomes and providing an essential safety net in clinical settings," says Dr. Kumar.
ResQ Pharma will provide further updates to investors and stakeholders during Q1 2025 as the company continues to work toward final FDA approval and commercialization.
About FDAMap Clinical
FDAMap Clinical is a full-service Contract Research Organization (CRO) offering expert regulatory, clinical trial management, and strategic guidance for biopharma and medical device companies. Led by Dr. Mukesh Kumar, FDAMap Clinical has a strong track record of bringing life-saving treatments like LipidRescue™ through the FDA approval process and into the hands of healthcare professionals.
The future of emergency care is here, and with the FDA’s acceptance of the LipidRescue™ NDA and the PDUFA date set, ResQ Pharma and FDAMap Clinical are paving the way for a new era in life-saving medical tools. Stay tuned for updates as this revolutionary treatment moves toward approval!
Stay informed on the latest developments by following FDAMap Clinical on LinkedIn and subscribing to our newsletter for ongoing updates on this and other groundbreaking projects at www.fdamapclinical.com or contact us directly.
Media Contact:
Rachel Greiner
Director of Business Development
FDAMap Clinical
Phone: 1-877-566-4981
Email: [email protected]
