What does an Abbreviated New Drug Application (ANDA) aim to demonstrate?

An Abbreviated New Drug Application (ANDA) specifically aims to demonstrate bioequivalence to a reference drug, which is typically a brand-name drug that has already been approved by the FDA. This is a critical aspect of the ANDA process because it allows a generic drug to enter the market without the need for the applicant to conduct the same extensive clinical trials required for a brand-name drug. Instead, the applicant must provide evidence that the generic product is therapeutically equivalent to the reference product in terms of its pharmacokinetic and pharmacodynamic properties.

Bioequivalence ensures that the generic version will perform in the same manner as the original drug when administered to patients, making it safe and effective. This focus on bioequivalence is what differentiates ANDAs from New Drug Applications (NDAs), which require comprehensive documentation on the safety and efficacy of new active ingredients. The emphasis is not on proving market exclusivity or clinical efficacy in the way that an NDA would require; instead, the goal is to confirm that the generic can be substituted for the reference drug without any significant differences in performance.