Source facts
FDA issued a tentative approval letter for SCOMARA on 2026-07-22. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
SCOMARA — FDA Tentative Approval Letter (NDA 218528)
Issued to AFT PHARMACEUTICALS LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
July 22, 2026Application
NDA 505b1 • 218528
Product
SCOMARA
Company
AFT PHARMACEUTICALS LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SCOMARA?
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: tentative approval.
- 2Application: NDA 218528.
- 3Submission: original application.
- 4Sponsor: AFT PHARMACEUTICALS LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SCOMARA tentative approval letter
Is SCOMARA FDA approved?
Not for marketing yet. FDA granted tentative approval to NDA 218528 for SCOMARA on July 22, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
What is NDA 218528?
NDA 218528 is the application under which FDA issued this tentative approval letter for SCOMARA to AFT PHARMACEUTICALS LTD. The letter is dated July 22, 2026.
What happens after an FDA tentative approval letter?
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.