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 If you use any medicine covered by those 39 NDAs, the approvals for those products are listed as withdrawn as of that date.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.
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