Briefing Summary: US FDA Posts Advisory Committee Materials for Ferring’s NOCDURNA for Nocturnal Polyuria – JAN 12, 2015 (EMDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Monday, January 12, 2015 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting. The committee will 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.