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 just what they sound like—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.
First Generic Drug Approvals - Previous Years
- 2018 First Generic Drug Approvals
- 2017 First Generic Drug Approvals
- 2016 First Generic Drug Approvals
- 2001-2015 ANDA approvals are archived. To view them, please see the FDA Archive