NVO

Novo Nordisk A/S

FDA PDUFA Target Action Date

Sunday, October 18, 2026

145 days away

Drug Information

Drug Name: CagriSema (cagrilintide + semaglutide) (CT.gov)
Application Type: NDA
Indication: Chronic weight management in adults with obesity or overweight

Filing Details

Company: Novo Nordisk A/S →
Stock Ticker: NVO
SEC CIK: 0000353278
Source: PRNewswire →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore Novo Nordisk A/S

View Novo Nordisk A/S's full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue