FDA Yanks Drug Approvals Over Missing Paperwork Reports
Published Date: 4/24/2026
Notice
Summary
The FDA is pulling the plug on three drug approvals because the companies didn’t send in their yearly reports like they were supposed to. This affects Egis Pharmaceuticals and others, and the change takes effect immediately on April 24, 2026. If you rely on these drugs, heads up—these products won’t be officially approved anymore, which could impact availability and sales.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Three generic drug approvals withdrawn
On April 24, 2026, the FDA withdrew approval of three abbreviated new drug applications (ANDAs). The affected ANDAs are ANDA 060453 (bacitracin‑neomycin sulfate‑polymyxin B sulfate ointment with diperodon hydrochloride) held by Ambix Laboratories; ANDA 074748 (captopril tablets 12.5 mg, 25 mg, 50 mg, 100 mg) and ANDA 074808 (piroxicam capsules 10 mg and 20 mg) both held by Egis Pharmaceuticals Ltd. The withdrawals are because the ANDA holders repeatedly failed to submit required annual reports and waived their opportunity for a hearing.
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