ARTICLE | Clinical News

FDA accepts NDA for Shire's prucalopride to treat constipation

March 9, 2018 6:59 PM UTC

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA accepted for review an NDA for prucalopride (SHP555) to treat chronic idiopathic constipation (CIC) in adults. Its PDUFA date is Dec. 21.

Shire markets prucalopride, an agonist of serotonin (5-HT4) receptor, in the EU as Resolor. The company obtained the drug’s U.S. rights from Johnson & Johnson (NYSE:JNJ) in 2012...

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