The Committee supported, by a vote of 14-Yes to 4-No, with no abstentions, the safety and efficacy of desmopressin nasal spray, submitted by Serenity Pharmaceuticals, LLC (Serenity). However, the Committee members who supported approval felt that the sponsor’s proposed indication, the treatment of adult onset nocturia, was too broad, and they instead preferred a narrower indication (e.g., adult nocturnal polyuria).
See the SAC Tracker report