JAN 12 EMDAC

Results Wire: US FDA Advisory Committee Does Not Support Ferring’s Nocdurna for Nocturnal Polyuria – JAN 12, 2015 (EMDAC)

On Monday, January 12, 2015, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) did not support, by a vote of 5-Yes to 10-No, with 2 abstentions, the safety and efficacy of Nocdurna (established name: desmopressin), orally disintegrating sublingual tablets, submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void.

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