Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Astellas Pharma
CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins87% CONFIDENCEOverall confidence: 87%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better
The FDA[1][5] drug safety communication carries the entry "12-16-2024 Update: FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury".The FDA adds a boxed warning, its most prominent, to Astellas' hot-flash pill Veozah after a patient suffered serious liver injury within about 40 days of starting it, and orders monthly liver tests for the first months.
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