What type of application is typically used for new uses of established drugs?

The correct answer is the New Drug Application (NDA). This application is used to seek approval from the FDA for new drugs and can also be applied for significant changes or new indications for established drugs. When a pharmaceutical company wants to expand the use of an already approved medication—whether it’s for a different condition or another patient population—they must submit an NDA to provide comprehensive data supporting the safety and efficacy of the new use. This can include clinical trial results specific to the new indication, which demonstrates the drug's potential benefits and risks in this different context.

The other choices represent different types of regulatory applications or processes. The Abbreviated New Drug Application (ANDA) is primarily used for generic drugs, allowing companies to market a product without having to repeat the extensive clinical testing that was required for the original NDA. A Supplemental New Drug Application (SNDA) is used for modifications to an approved NDA, such as changes in production methods or indications, but it is not the primary application for introducing a new use. The OTC monograph process pertains to over-the-counter medications, establishing standards and conditions for marketing without needing to submit an NDA. Understanding these distinctions is critical for navigating pharmaceutical regulations effectively.