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.

中文翻译：

---

小剂量去氨加压素鼻喷雾剂和FDA批准

向编辑Fralick和Kesselheim博士¹提出了对去氨加压素鼻喷雾剂（Noctiva，Serenity Pharmaceuticals）的关注，该药已获美国食品和药物管理局（FDA）批准用于夜尿，潜在的安全性问题和临床有效性。他们的观点包含错误陈述，涉及临床数据，程序和FDA批准的依据。