NRX PHARMACEUTICALS INC · Data as of 2026-09-08
in 2026
Although no assurances can be given on regulatory determinations, management is optimistic that the identified concern related to packaging will be resolved in a timely manner, consistent with first commercial sales in 2026, given that FDA has recognized the current drug shortage and lack of U.S.-based supply of ketamine and has committed to completing the review in the shortest possible review time frame.Source filing
2026
This attestation has been provided to the FDA and the Company aims for 2026 approval and commercialization.Source filing
Summer 2026
The Company is aware of no impediments to an acceptance of the ANDA package and anticipates regulatory action in the summer of 2026.Source filing
2027
With alignment on the drug packaging matter, the Company is now poised to finalize its NDA, aiming for 2027 approval.Source filing
2027
Success in this planned clinical trial would lead to a 2027 PDUFA date for this previously unanticipated indication.Source filing