If a drug is found to have a new indication, which regulatory action should the manufacturer consider taking?

When a drug is discovered to have a new indication, the appropriate regulatory action for the manufacturer is to submit a supplemental New Drug Application (NDA). This process is essential because a new indication typically involves using the existing drug for a different condition than what it was originally approved for.

Submitting a supplemental NDA allows the manufacturer to provide the FDA with new data and information regarding the safety and efficacy of the drug for the new indication. This is necessary for regulatory compliance and ensures that the drug's labeling reflects the new use, which is crucial for informing healthcare providers and patients accurately.

This regulatory pathway not only addresses the new indication but also helps in maintaining a clear record of the drug's uses in the market, thus protecting public health. Further research on its own, while potentially beneficial, does not fulfill the regulatory requirements needed to officially change or expand the recognized uses of the drug. Other options, such as marketing the drug under a different name or filing for a patent extension, do not address the necessary approval process for a new indication and therefore would not be appropriate actions in this context.