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Gastrointestinal Drugs Advisory Committee

On Thursday, October 18, 2018, the Gastrointestinal Drugs Advisory Committee (GIDAC) met to discuss a new drug application (NDA) for Motegrity (prucalopride) tablets for oral administration, submitted by Shire Development, LLC (Shire), proposed for the treatment of chronic idiopathic constipation in adults.

The committee voted unanimously (10 of 10 members) that the clinical trial data provide substantial evidence of effectiveness of prucalopride for the treatment of adults with chronic idiopathic constipation (CIC).