Source facts
FDA issued an approval letter for MACRILEN on 2026-07-27. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MACRILEN — FDA Approval Letter (NDA 205598)
Issued to AETERNA ZENTARIS. Application is approved as submitted.
Issued
July 27, 2026Application
NDA 505b1 • 205598
Product
MACRILEN
Company
AETERNA ZENTARIS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for MACRILEN?
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 205598.
- 3Submission: supplement.
- 4Sponsor: AETERNA ZENTARIS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MACRILEN approval letter
Is MACRILEN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 205598 for MACRILEN, sponsored by AETERNA ZENTARIS, on July 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 205598?
NDA 205598 is the application under which FDA issued this approval letter for MACRILEN to AETERNA ZENTARIS. The letter is dated July 27, 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.