Label Expansion

What is a supplemental label expansion? 

Label expansion refers to the process of updating the official label or prescribing information of a pharmaceutical product to include additional indications, patient populations, or uses that were not originally approved at the time of initial regulatory approval. This may involve new therapeutic areas, age groups, or specific conditions based on new clinical evidence or real-world data. 

Why is supplemental label expansion important? 

Label expansion is essential for ensuring that effective treatments are available to a broader range of patients. By updating product labels to reflect new uses, patient populations, or evidence, label expansion helps improve patient care and supports the continued success of pharmaceutical products in the marketplace.