As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III), the Food and Drug […]

Abacavir/ dolutegravir/ lamivudine ViiV Healthcare Company 6/7/2023 Abatacept BMS 2/14/2017  Acetaminophen Mallinckrodt 7/11/2016 Afatinib  Boehringer Ingelheim Pharmaceuticals, Inc. 3/8/2022 Aflibercept Regeneron Pharmaceuticals 10/18/2022 Albuterol GlaxoSmithKline 8/27/2008 […]

3/27/2024 3007621329 Zydus Lifesciences Limited 483 India 4/12/2024 4/4/2024 3002806710 Cipla Limited 483 India 4/10/2024 3/27/2024 3006370533 Alkem Laboratories Limited 483 India 4/9/2024 2/2/2024 3006895982 Jubilant […]

Docket Number: FDA-2022-D-0738 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics Center for Biologics Evaluation […]

Updated April 11, 2024 Note:This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the […]

For Immediate Release: May 23, 2019 Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies […]

Who is affected by high blood pressure? Nearly half, more than 119 million, American adults have high blood pressure. But only about 1 in 4 of […]

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through […]

With the start of GDUFA III in FY 2023, the Generic Drugs Program monthly and quarterly activities reports were combined into one report. Also, reported metrics […]