FDA Corrects Typo in Cancer Drug Approval Withdrawal Notice
Published Date: 10/3/2025
Notice
Summary
The FDA fixed a mistake in their August 4, 2025, announcement about pulling approval for 39 drug applications. They accidentally listed the wrong drug number for Zinecard, a cancer treatment medicine, and now corrected it. This change affects drug makers and users by making sure the right drug info is clear before the September 3, 2025 deadline.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Approval Withdrawals for 39 NDAs
The FDA announced the withdrawal of approval for 39 new drug applications (NDAs), with the withdrawals effective September 3, 2025. If you use any medicine covered by those 39 NDAs, the approvals for those products are listed as withdrawn as of that date.
Correction of Zinecard NDA Number
The FDA corrected an error in its August 4, 2025 notice: the correct NDA number for Zinecard (dexrazoxane HCl) Injectable is NDA 020212 (not NDA 021290). The correction lists Zinecard in EQ 250 mg base/vial and EQ 500 mg base/vial and clarifies the record before the September 3, 2025 withdrawal date.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-13047 — Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-13716 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The FDA just updated the rules for new animal drugs, approving several new and generic medicines for pets and farm animals from early 2026. These changes help keep animal treatments safe and effective, and the updates take effect right away on July 7, 2026. If you’re a drug maker or animal caretaker, these approvals and sponsor changes could impact what medicines are available and when.
2026-13616 — Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
The FDA is officially pulling the plug on 34 drug approvals because the companies stopped selling these medicines. This change kicks in on August 5, 2026, and it mainly affects drug makers like Endo Operations and Pfizer. No money penalties here—just a clean break, but companies can ask to reapply if they want to bring the drugs back.
2026-13519 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
The FDA is asking for public feedback on their paperwork rules for approving the most important and risky medical devices, like life-support machines. This review helps keep devices safe and effective before they hit the market. If you have thoughts, you’ve got until August 5, 2026, to share them—no cost changes, just a check-in on the info they collect.
2026-13534 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!
2026-13533 — Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
The FDA wants your thoughts on how it collects info for biologics license applications—basically, the paperwork needed to approve new biological medicines. This affects companies making these medicines and anyone involved in the approval process. You’ve got until September 4, 2026, to share your comments, so don’t miss out on shaping the rules and possibly saving time and money!
Previous / Next Documents
Previous: 2025-19436 — URAL Airlines JSC, Utrenniy Lane 1-g, Yekaterinburg, Russia 620025; Order Renewing Temporary Denial of Export Privileges
URAL Airlines from Russia is still banned from exporting certain goods because they’ve repeatedly broken the rules. This export ban, first started in 2022, has been renewed again to keep things safe and legal. The ban means URAL can’t do business with U.S. exports for now, and this will continue until further notice.
Next: 2025-19441 — Astronomy and Astrophysics Advisory Committee; Notice of Meeting
The Astronomy and Astrophysics Advisory Committee is meeting virtually on November 7, 2025, to hear updates from NASA, NSF, DOE, and others about space science projects. They’ll talk about teamwork between agencies and plan recommendations to boost future space research. Anyone interested can join online, and the committee’s report is due by March 15, 2026.