Posted by Merck Sharp & Dohme LLC has submitted supplemental new drug application which was received on June 12, 2024 by FDA for Bridion® (sugammadex) injection.
This request proposed to update Bridion Prescribing Information for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age, based on the data submitted from Study P169 – A Phase IV Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8618) for Reversal of Neuromuscular Blockade Induced by Either Rocuronium or Vecuronium in Pediatric Participants Age Birth to < 2 Years.
Followed by Merck’s request, Bridion injection has been approved on December 12, 2024 for use in pediatric patients ages from birth to less than 2 years old for reversal of neuromuscular blockage induced by rocuronium bromide and vecuronium bromide.
The obsolete label may be accessed here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022225Orig1s012lbl.pdf
The new label is uplodaded here with changed text in section “INDICATIONS AND USAGE” https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022225s014lbl.pdf
Source: FDA (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022225Orig1s014ltr.pdf)