Shire PLC said the U.S. Food and Drug Administration accepted its application for a constipation drug for review.
The Irish biotechnology company is seeking approval for prucalopride, also known as SHP555, to treat chronic idiopathic constipation.
The regulator is expected to make a decision by Dec. 21.
Chronic idiopathic constipation is a common condition affecting nearly one in eight people in the U.S.
Prucalopride is already approved in the European Union and is marketed as Resolor.
