WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced it has received U.S. Food and Drug Administration (FDA) approval of a Suitability Petition allowing the company to proceed with its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free ketamine product.
Currently, ketamine is available only in multi-dose vials containing Benzethonium Chloride, a preservative flagged as toxic. KETAFREE™ is designed as a single-patient, preservative-free formulation, aligning with federal priorities to reshore critical drug production and eliminate harmful additives from medical and consumer products.
The U.S. ketamine market is estimated at $750 million annually. NRx expects KETAFREE™ to compete in this market while also advancing its broader pipeline, including NRX-100, a proprietary ketamine-based therapy under development for suicidal depression and PTSD.
“[NRx] was honored to be selected to attend a listening session hosted by the FDA Commissioner for biotechnology CEOs,” said Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “We appreciate FDA’s rapid response on the requested Suitability Petition and look forward to bringing our preservative-free presentation of ketamine to the U.S. market at the earliest possible moment.”
The company said the approval marks an important step in supporting both domestic drug manufacturing and patient safety, reinforcing its position in the growing ketamine treatment landscape.
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