Issued to GENENTECH INC. Application is approved as submitted.
Posted by FDA
October 5, 2026Application
NDA 505b1 • 212725
Product
ROZLYTREK
Company
GENENTECH INC
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA posted an approval letter for ROZLYTREK on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212725, NDA 218550 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 212725 for ROZLYTREK, sponsored by GENENTECH INC,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 212725 is the application under which FDA issued this approval letter for ROZLYTREK to GENENTECH INC. FDA posted the letter on October 5, 2026; the posting date is not the decision date.
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.