Source facts
FDA issued an approval letter for INGREZZA SPRINKLE on 2026-04-09. The source metadata identifies NDA 218390 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
INGREZZA SPRINKLE — FDA Approval Letter (NDA 218390)
Issued to NEUROCRINE. Application is approved as submitted.
Issued
April 9, 2026Application
NDA 505b1 • 218390
Product
INGREZZA SPRINKLE
Company
NEUROCRINE
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for INGREZZA SPRINKLE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 218390.
- 3Submission: supplement.
- 4Sponsor: NEUROCRINE.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the INGREZZA SPRINKLE approval letter
Is INGREZZA SPRINKLE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 218390 for INGREZZA SPRINKLE, sponsored by NEUROCRINE, on April 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 218390?
NDA 218390 is the application under which FDA issued this approval letter for INGREZZA SPRINKLE to NEUROCRINE. The letter is dated April 9, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.