WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) received a revised Nov. 10 regulatory goal date for its preservative-free ketamine application after the U.S. Food and Drug Administration reclassified a filing amendment from major to minor, reducing the regulatory resources required for the review.
The clinical-stage biopharmaceutical company said it received written communication from the director of regulatory operations in the FDA’s Office of Generic Drugs concerning its Abbreviated New Drug Application, or ANDA.
The amendment relates to the drug vial for preservative-free ketamine. It had previously been classified as a Major Amendment but is now considered a Minor Amendment.
The FDA revised the Generic Drug User Fee Amendments, or GDUFA, goal date to Nov. 10, according to NRx.
The agency cited the reclassification in determining that the amendment would not require a substantial expenditure of FDA resources, the company said.
NRx Chairman and Chief Executive Officer Jonathan Javitt characterized the regulatory development as advancing the approval process for a product the company describes as addressing a drug shortage.
“On behalf of our patients and our shareholders, we are deeply appreciative of the speed with which FDA’s leadership has moved to advance the approval process of this strategic, drug shortage product,” Javitt said.
The revised goal date establishes the FDA’s current target for action on the application; the company did not report an approval decision.
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