NRx Pharmaceuticals Receives FDA Approval Of Its Abbreviated New Drug Application For Preservative-Free Ketamine

The approval comes ahead of the FDA-announced November 10, approval goal date.

Preservative-Free Ketamine is an American-manufactured presentation of ketamine that contains no benzethonium chloride (BZT), a toxic antimicrobial preservative that is not Generally Recognized as Safe (GRAS) by the FDA. Current law requires preservatives and other inactive ingredients of drugs, foods, and cosmetics to be GRAS or demonstrated to be unsafe.
Benzethonium Chloride is known to be toxic to the cells that line the body’s organs (epithelial cells) and is banned from new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs 1,2
Ketamine, originally formulated in 1970 is one of the last remaining sterile drugs to contain Benzethonium Chloride.
NRx aims to return sterile, injectable drug manufacture to the United States and to end the current shortage of traditional glass-bottled ketamine through modern, high-volume "blow-fill-seal" technology, manufactured in the United States with Nephron Pharmaceuticals in West Columbia, South Carolina.
This approval demonstrates that sterile, injectable drug manufacturing can be reshored to the United States from current overseas sources of supply using modern technology for the benefit of American patients, workers, and their families.
The Company will host a conference call Friday, October 30, at 8:30 a.m. ET.