Oclaiz (CAM2029, octreotide subcutaneous depot)

FDA PDUFA Target Action Date · Camurus AB

Wednesday, June 10, 2026

28 days ago

pending

Drug Information

Drug Name: Oclaiz (CAM2029, octreotide subcutaneous depot) (CT.gov)

Filing Details

Company: Camurus AB
SEC CIK: manual
Source: SEC 8-K Filing →

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

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: manual. Report an issue