FDA Yanks Drug Approvals Over Forgotten Yearly 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 withdrawal is official as of April 24, 2026. If you rely on these drugs, heads up—these changes could impact availability and business.
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Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
FDA Withdraws Three ANDA Approvals
The FDA withdrew approval of three abbreviated new drug applications (ANDAs) as of April 24, 2026 because the holders repeatedly failed to file required annual reports. The withdrawn ANDAs are ANDA 060453 (bacitracin‑neomycin sulfate–polymyxin B sulfate ointment with diperodon hydrochloride) held by Ambix Laboratories; ANDA 074748 (captopril tablets in listed strengths including 12.5 mg, 25 mg, 50 mg, and 100 mg) held by Egis Pharmaceuticals Ltd.; and ANDA 074808 (piroxicam capsules, 10 mg and 20 mg) held by Egis Pharmaceuticals Ltd.
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