The FDA has declined to approve a medication developed by Allergan to treat abnormal bleeding in women with uterine fibroids.
Regulators in Europe have already placed restrictions on the drug, Esmya, due to concerns it can cause rare but serious liver damage. The FDA cited “safety concerns regarding Esmya post-marketing reports outside the U.S.,” in its announcement that it is rejecting the drug all together.
One analyst called the decision a “setback” for Allergan’s plan to sell off its women’s health and infectious disease division, but said that investors “will likely not be disturbed” by the news.
Uterine fibroids are a common condition that affect about 200,000 women in America each year.