FDA Lists 72 "First Generic" Drug Approvals of 2016

Nov. 16, 2016

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 that 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.

Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.

Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.

View the list here