Tecentriq Breast Cancer Indication Withdrawn
August 27, 2021
Keytruda Granted Full Approval for Urothelial Carcinoma Indication
August 31, 2021
Tecentriq Breast Cancer Indication Withdrawn
August 27, 2021
Keytruda Granted Full Approval for Urothelial Carcinoma Indication
August 31, 2021

August 30, 2021 – Due to an expanded indication granted by the U.S. FDA, Briviact® (brivaracetam) tablets, oral solution, and injection for intravenous (IV) use are now approved to treat partial-onset seizures in patients who are at least one month old.

  • Previously, Briviact tablets and oral solution were approved only for use in individuals four years old and up, while Briviact for IV was approved only for patients at least 16 years of age.
  • Recommended dosing is the same for Briviact tablets, oral solution, and injection for IV use:
    • Ages 16 years and up: 25mg to 100mg twice daily, based on tolerability and therapeutic response.
    • Ages one month to less than 16 years: Twice daily, with total daily dose based on weight, tolerability, and therapeutic response.
  • Briviact for IV should only be used when administering oral formulations (tablets, oral solution) is temporarily not feasible.
  • The FDA first approved Briviact in 2016.