FDA declines to approve Allergan's Esmya
Allergan Plc said U.S. health regulators had declined to approve Esmya, its treatment for abnormal uterine bleeding in women with uterine fibroids, requesting more information and citing safety issues outside the United States.
The safety concerns raised could impact the company's plan to sell its women's health business.
Earlier this year, regulators in Europe slapped temporary restrictions on the use of the drug, after reports that it was linked to serious liver damage.
Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at email@example.com. Check out more about our bureau/team here