Aug 21 (Reuters) - Allergan Plc said on Tuesday 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 drugmaker said it plans to meet with the U.S. Food and Drug Administration to determine the potential next steps for Esmya.
The decision could impact the company’s plan to sell its women’s health business.
Allergan said in May it planned to sell that business as well as its infectious disease unit, as it works to reverse a steep slide in its shares. Allergan Chief Executive Brent Saunders said last month that potential bidders were waiting to see how the FDA would handle Esmya’s approval in order to properly value the women’s health business.
Earlier this year, regulators in Europe recommended restrictions on the use of the drug for some patients, to help minimize the risk of rare but serious liver injury associated with Esmya.
The drug is sold in Europe by Hungarian drugmaker Richter . Richter has said it considered Esmya to be a safe and effective form of treatment. (Reporting by Tamara Mathias in Bengaluru and Michael Erman in New York; editing by Maju Samuel and Rosalba O’Brien)