Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the […]

FDA has revoked the Emergency Use Authorization for bamlanivimab administered alone, bamlanivimab and etesevimab administered together, and REGEN-COV. For more information, see FDA’s webpage for archived […]

For Immediate Release: December 23, 2024 Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like […]

FDA’s Center for Drug Evaluation and Research (CDER) has finalized the rule, Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU). The rule is […]

FDA recognizes the benefit of providing consumers with options for additional types of nonprescription drugs, such as some drugs that are currently available only by prescription […]

[12/23/2024] Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use […]