Source facts
FDA issued an approval letter for TEPYLUTE on 2026-01-23. The source metadata identifies NDA 216984 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TEPYLUTE — FDA Approval Letter (NDA 216984)
Issued to SHORLA. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for TEPYLUTE?
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: NDA 216984.
- 3Submission: supplement.
- 4Sponsor: SHORLA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the TEPYLUTE approval letter
Is TEPYLUTE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216984 for TEPYLUTE, sponsored by SHORLA, on January 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216984?
NDA 216984 is the application under which FDA issued this approval letter for TEPYLUTE to SHORLA. The letter is dated January 23, 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.