FDA reclassifies NRx's generic ketamine amendment from Major to Minor, setting a November review goal after a vial-cap deficiency

FDA reclassified NRx Pharmaceuticals' amendment to its generic, preservative-free ketamine ANDA from Major to Minor on September 15, setting a new GDUFA goal date of November 10, 2026. The amendment became Major after FDA identified a potential deformation problem with the twist-off, luer-lock vial cap, a container-closure issue that emerged after the original July 29 goal date had passed. The reclassification shortens the likely review timeline compared with the eight-to-ten-month Major-Amendment process, but it does not restore the original schedule. Nor does it mean ketamine supply will reach hospitals by November: the candidate remains unapproved and would still require manufacturing and distribution after any FDA decision. The ANDA is separate from NRx's NRX-100 NDA for suicidal ideation, and the November date remains a decision point rather than a guaranteed approval.