Label Expansion (Supplemental Indication)
When a drug gets FDA approval for an additional use beyond its original indication.
Label expansion happens when a drug's sponsor gets FDA approval to add a new indication, a new disease, patient population, or use, beyond what the drug was originally approved for. It's granted through a supplemental application (an sNDA or sBLA) rather than a brand-new approval, but the effect on the PI is real: the label changes, and so does what counts as on-label.
Every promotional claim built for the new indication needs its own path through MLR, since claims approved for the original indication don't automatically cover the new one. In practice, a label expansion means the approved claim set in a brand's dossier has to be updated before generation can reflect the new indication accurately, which is exactly what the claims-linked stage checks against before anything renders.