Background Analysis: US FDA Advisory Committee to Review for Ferring’s NOCDURNA for Nocturnal Polyuria – JAN 12, 2015 (EMDAC)
The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting for Monday, January 12, 2015 to discuss the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. (Ferring). The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void.