Comments Sought on Pre-Hatch-Waxman ANDAs

Federal Register notice: FDA has established a public docket to solicit comments on several issues related to FDA’s post-approval regulation of certain drug products approved in abbreviated applications before the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish the current ANDA process. The agency says that because these pre-Hatch-Waxman ANDAs (referred to as “PANDAs”) were submitted and approved under the provisions of the FD&C Act that apply to 505(b) new drug applications, they can serve as a reference-listed drug for ANDAs and can also be a listed drug relied on by 505(b)(2) applications. FDA is seeking input from PANDA holders and other interested persons on whether there are regulatory or policy rationales for treating PANDAs differently from other 505(b) applications in certain respects. To view the notice, click here.