Source facts
FDA issued an approval letter for QUILLICHEW ER on 2026-03-12. The source metadata identifies NDA 207960 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
QUILLICHEW ER — FDA Approval Letter (NDA 207960)
Issued to NEXTWAVE PHARMS. Application is approved as submitted.
Issued
March 12, 2026Application
NDA 505b1 • 207960
Product
QUILLICHEW ER
Company
NEXTWAVE PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for QUILLICHEW ER?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 207960.
- 3Submission: supplement.
- 4Sponsor: NEXTWAVE PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the QUILLICHEW ER approval letter
Is QUILLICHEW ER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 207960 for QUILLICHEW ER, sponsored by NEXTWAVE PHARMS, on March 12, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 207960?
NDA 207960 is the application under which FDA issued this approval letter for QUILLICHEW ER to NEXTWAVE PHARMS. The letter is dated March 12, 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.