FDA Office of Generic Drugs 2021 Annual Report

The US Food and Drug Administration published the 2021  Office of Generic Drugs (OGD) Annual Report.

Generic drugs play a vital role in facilitating access to lifesaving medicines and remain a considerable public health priority for the FDA. In 2021, with the new realities and unique challenges created by another year of the pandemic, OGD staff innovated and collaborated to keep the generic drug program on course and moving forward.

The FDA approved hundreds of abbreviated new drug applications (ANDAs), thousands of application supplements, and funded around $20 million in generic drug science and research programs. It has prioritized assessment of generic drug submissions for potential treatments and supportive therapies for patients with COVID-19, including more than 75 original ANDAs, some in record time, along with more than 1,200 supplemental approvals.