If a marketed drug product has a new use for another condition, what must the manufacturer do to claim this indication?

When a manufacturer wishes to claim a new use for a marketed drug product for a different condition, they must submit a supplemental New Drug Application (NDA) to the FDA. This process is essential because the new indication often requires that the manufacturer provide evidence of the drug's safety and efficacy for the new condition based on appropriate data.

A supplemental NDA is designed to allow manufacturers to add new indications or expand the label of existing drugs without needing to submit an entirely new application. This helps streamline the process while ensuring that all claims made about the drug are based on sufficient scientific evidence to protect patients and maintain public health integrity.

In contrast, a new drug application would be necessary if a completely new drug or product was being introduced to the market rather than just adding new indications to an existing drug. Conducting clinical trials, while potentially necessary to gather evidence for the new use, is not an independent requirement to make the claim unless the FDA specifically asks for this data. Notifying the FDA of the change does not suffice by itself because it does not fulfill the regulatory requirements for officially recognizing the new indication. The submission of a supplemental NDA captures all necessary documentation for the new use.