FDA seeks feedback on drugs approved under ANDAs prior to enactment of the Hatch-Waxman amendments

The US Food and Drug Administration (FDA) has established a  public docket to solicit comments on issues related to the agency’s regulation of certain drug products approved under abbreviated new drug applications (ANDAs) before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Amendments.

Since these pre-Hatch-Waxman ANDAs (PANDAs) were submitted under section 505(b) and approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act, they can serve as a reference listed drug (RLD) for future abbreviated new drug applications submitted under section 505(j) of the FD&C Act (505(j) ANDAs) and can also be a listed drug relied on by 505(b)(2) applications.

Although these PANDAs are 505(b) applications, they have historically been overseen by the FDA’s Office of Generic Drugs.