FDA rejects professor’s petition seeking to pull ‘dangerous’ Otsuka kidney disease drug
The FDA on Monday denied a petition from an emeritus professor at Ohio State University who had sought to revoke the approval of Otsuka’s kidney disease drug tolvaptan, which he said is “dangerous” and offered “negligible efficacy.”
Approved by the FDA in 2018 to treat the genetic disease known as autosomal dominant polycystic kidney disease, Otsuka’s tolvaptan — marketed in the US as Jynarque — faced a long and rocky road to marketing but quickly amassed more than $700 million in worldwide sales in 2020, up almost 40% from 2019.
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