Unicycive Therapeutics resubmits new drug application for oxylanthanum carbonate
UNCY•Unicycive Therapeutics resubmitted its new drug application for oxylanthanum carbonate; FDA acceptance is expected within 30 days, with a new PDUFA date in six months.
1. NDA resubmission
The resubmission includes CMC data from a new manufacturing vendor. An FDA inspection of the original manufacturing vendor had been assigned but was not completed as of September 29, 2026.
