Source facts
FDA issued an approval letter for APREPITANT on 2026-06-09. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
APREPITANT — FDA Approval Letter (ANDA 218851)
Issued to MYLAN. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for APREPITANT?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 218851.
- 3Submission: original application.
- 4Sponsor: MYLAN.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the APREPITANT approval letter
Is APREPITANT FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 218851 for APREPITANT, sponsored by MYLAN, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 218851?
ANDA 218851 is the application under which FDA issued this approval letter for APREPITANT to MYLAN. The letter is dated June 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.