Supplemental New Drug Application (sNDA)
A submission to the FDA to modify an existing drug approval — for example, to add a new indication, change dosing, update safety information, or modify the formulation. Semaglutide's separate weight management indication (Wegovy) required an sNDA building on the original diabetes approval (Ozempic).
Technical Context
sNDA types include: efficacy supplements (new indication based on new clinical trials — e.g. semaglutide weight management sNDA supported by STEP trial programme), safety supplements (new safety information, revised warnings), CMC supplements (manufacturing changes, new formulation — e.g. new pen device), and labelling supplements (revised prescribing information). The regulatory pathway for new indications of approved drugs parallels new drug development: Phase II dose-finding and Phase III pivotal trials are typically required, though the preclinical and manufacturing modules may rely on existing data. sNDA review follows the same PDUFA timelines as original NDAs. For blockbuster peptide drugs like semaglutide, multiple sNDAs may be filed to expand indications (diabetes → weight management → NASH → cardiovascular risk reduction → chronic kidney disease).