Three Lilly Drugs Among 44 Approvals Withdrawn By FDA

The FDA is withdrawing its approval of three NDAs and 41 ANDAs at the request of the drugs’ manufacturers. None of the drugs is currently being marketed.

The NDAs are all cephalosporin antibiotics made by Eli Lilly: Keflet (cephalexin) tablets, Keftab (cephalexin HCl) tablets and Ceclor CD (cefaclor) tablets.

Among the generic drugs being withdrawn are Mylan’s famotidine tablets USP, Nesher’s doxazosin mesylate tablets, Sandoz’s etodolac extended-release tablets and Hospira’s famotidine injection. ANDAs by Teva, Bedford Laboratories, Baxter, Barr Laboratories, Aegis Pharmaceuticals, Ranbaxy, Pliva and Synthon Pharmaceuticals make up the remainder of the list.

The withdrawals take effect May 22. View the list of Federal Register notice at www.fdanews.com/ext/resources/files/04/04-22-14-Approval.pdf. — Lena Freund

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