FDA turns thumbs down on Al­ler­gan's op­ti­mistic case for uter­ine fi­broid drug as liv­er dam­age threat tor­pe­does ap­pli­ca­tion

One of Al­ler­gan’s $AGN top late-stage drugs just ran in­to a brick wall at the FDA.

The com­pa­ny not­ed Tues­day evening that the agency turned thumbs down on its mar­ket­ing ap­pli­ca­tion to start sell­ing ulipristal ac­etate for the treat­ment of ab­nor­mal uter­ine bleed­ing in women with uter­ine fi­broids. The state­ment is a lit­tle hazy on specifics, but Al­ler­gan cit­ed safe­ty con­cerns raised out­side the US — where the drug is al­ready avail­able.

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