What is required of an ANDA regarding bioequivalence?

An Abbreviated New Drug Application (ANDA) must demonstrate that the generic drug is bioequivalent to the Reference Listed Drug (RLD). Bioequivalence means that the two drugs have the same rate and extent of absorption in the body, ensuring that the generic product performs in the same way as the branded drug. This requirement is crucial because it assures healthcare providers and patients that the generic product can be used as a substitute for the RLD without compromising safety or efficacy.

Demonstrating bioequivalence typically involves conducting studies that assess how the drug is absorbed, distributed, metabolized, and excreted. This requirement aligns with the regulatory framework that seeks to ensure that generic medications provide the same therapeutic effect while being more cost-effective.

The other potential options, while relevant in different contexts, do not apply to the specific requirements of an ANDA concerning bioequivalence. For example, demonstrating safety and efficacy through clinical data is more aligned with a New Drug Application (NDA) rather than an ANDA. Thus, the focus on bioequivalence is a distinct and fundamental aspect of the ANDA process.