Cannabidiol PDUFA date: FDA decision expected April 16, 2027
The FDA is expected to decide on Cannabidiol from Jazz Pharmaceuticals plc in Sturge-Weber Syndrome by the PDUFA target action date of April 16, 2027. NDA filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked November 6, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
Get an email when this FDA date moves or the decision lands
Track Jazz Pharmaceuticals plc (JAZZ) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Questions about this FDA decision
- When is the PDUFA date for Cannabidiol?
- The FDA's PDUFA target action date for Cannabidiol is April 16, 2027. The FDA can act before that date, and the review can be extended.
- What is Cannabidiol being reviewed for?
- The application under FDA review covers Sturge-Weber Syndrome.
- Which company is developing Cannabidiol?
- Jazz Pharmaceuticals plc (JAZZ).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).