Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.
“First generics” are the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.
As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) that is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.