[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling:
- Add or modify an indication or claim;
- Revise the dose or dose regimen;
- Provide for a new route of administration;
- Make a comparative efficacy claim naming another drug product;
- Significantly alter the intended patient population;
- Incorporate other information based on at least one adequate and wellcontrolled clinical study.
Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements