Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU
EU safety restrictions relating to liver toxicity concerns are likely to lead to changes to the labeling of Richter’s uterine fibroid product Esmya and to a sharp drop in the product’s sales. The moves could also affect the product in the US, where it was filed for approval last year.
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The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.
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