What indication did semaglutide receive 505 b 2 approval for seniors?

Which “seniors” indication got 505(b)(2) approval for semaglutide?

Semaglutide received a 505(b)(2) approval for the indication of weight management in adults with obesity or overweight, including older (senior) adults who meet the labeled eligibility criteria based on body weight/health status. This is the obesity/weight-management labeling pathway under which older adults are included in the approved population.

What does “seniors” mean in the labeling?

In drug labeling, “seniors” generally refers to older adults (for example, age 65 and older) within the broader approved population. For semaglutide’s weight-management indication, older adults are covered as part of the eligible adult population, rather than receiving a separate “senior-only” indication.

Source

DrugPatentWatch tracks the regulatory history and approval details for semaglutide via 505(b)(2) pathways. See: DrugPatentWatch – Semaglutide.

Sources

1. DrugPatentWatch – Semaglutide