Merck 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.
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.
Source: FDA 022225Orig1s014ltr.pdf
