What is an Abbreviated New Drug Application (ANDA)?

An Abbreviated New Drug Application (ANDA) is specifically designed for the approval of generic drugs. It allows a manufacturer to submit an application to the FDA that demonstrates that the generic product is bioequivalent to the already approved brand-name drug. This means that the generic can be expected to have the same therapeutic effect, safety profile, and efficacy as the original drug while typically being offered at a lower cost.

The ANDA process does not require the manufacturer to conduct all the same preclinical and clinical studies that the original drug sponsor did, allowing for a more streamlined approval process. Instead, it relies on the FDA's previous findings regarding the safety and efficacy of the brand-name product, thus reducing the time and cost associated with bringing generic drugs to market. This ultimately benefits consumers by promoting competition and making medications more affordable.

Other options do not accurately describe the purpose or function of an ANDA. For instance, requests to raise prices or applications for unapproved drugs do not pertain to the procedural and regulatory framework established for generic medications, while applications specifically for rare diseases would involve a different set of guidelines under the Orphan Drug Act rather than an ANDA format.