Sucampo Halts Tacrolimus Eye Drop Program, Sues Fujisawa
This article was originally published in The Pink Sheet Daily
Executive Summary
The company sues Fujisawa for failing to disclose material safety concerns with tacrolimus prior to an FDA advisory committee review of Fujisawa's topical tacrolimus product Protopic. FDA subsequently added a "black box" warning for potential carcinogenicity to Protopic.