Understanding FDA Approval

An approval decision covers a defined indication in a defined population, supported by trials in that population. The prescribing label is the legal record of what was demonstrated.

Approval for one indication is not evidence for another. Semaglutide's diabetes approval and its weight-management approval rested on separate trial programmes.

Compounding is not approval

A compounded preparation is made for an individual patient and has not been through the approval process. Availability through a compounding pharmacy says nothing about approval status.