On August 21, 2018 the drug company Allergan Plc announced that the FDA has declined to approve Esmya, its treatment for abnormal uterine bleeding in women with uterine fibroids.
Instead, the FDA is requesting more information about drug safety issues concerning Esmya, which has been approved for use in Europe.
Notably, earlier this year European drug regulators put restrictions on the use of Esmya while they investigate reports that Esmya is linked to serious liver damage.
We have covered that Esmya drug safety issue previously in this February 2018 article, "Uterine Fibroid Drug Esmya Investigated Due to Severe Liver Injuries".
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