> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Serenity Asks FDA to Refuse Approval of Ferring’s Nocdurna
- URL: https://www.fdaweb.com/serenity-asks-fda-to-refuse-approval-of-ferrings-nocdurna/
- Published: 2018-05-07T12:00:00.000Z
- Updated: 2026-09-15T00:03:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141377

Serenity Pharmaceuticals has petitioned FDA asking it to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treating nocturia. Serenity is the NDA holder for Noctiva (desmopressin acetate) nasal spray.

In the [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-1760-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com), Serenity requests that FDA deny approval because Ferring has not demonstrated its drug is safe use in patients with nocturia, and the design of its studies does not allow for a true assessment of the product’s safety risks. Serenity also argues that based on a “comprehensive comparative analysis of Ferring’s clinical data with that of Noctiva, there is no compelling reason for FDA to approve another drug that may be less safe and effective for the same clinical indication.”