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Comment & Response
September 19, 2017

Low-Dose Desmopressin Nasal Spray and FDA Approval

Author Affiliations
  • 1Serenity Pharmaceuticals, Milford, Pennsylvania
JAMA. 2017;318(11):1070-1071. doi:10.1001/jama.2017.11327

To the Editor Drs Fralick and Kesselheim1 raised concerns about desmopressin nasal spray (Noctiva, Serenity Pharmaceuticals), its approval by the US Food and Drug Administration (FDA) for nocturia, potential safety issues, and clinical effectiveness. Their Viewpoint contains misstatements involving the clinical data, the program, and the basis for FDA approval.