Source facts
FDA issued an approval letter for IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE on 2026-02-06. The source metadata identifies NDA 050734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE — FDA Approval Letter (NDA 050734)
Issued to PFIZER. Application is approved as submitted.
Issued
February 6, 2026Application
NDA 505b1 • 050734
Product
IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE
Company
PFIZER
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE?
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 050734.
- 3Submission: supplement.
- 4Sponsor: PFIZER.
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 IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE approval letter
Is IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050734 for IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE, sponsored by PFIZER, on February 6, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 050734?
NDA 050734 is the application under which FDA issued this approval letter for IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE to PFIZER. The letter is dated February 6, 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.