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Maxim withdraws Ceplene NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Maxim is withdrawing the NDA for use of its H2 receptor antagonist Ceplene (histamine dihydrochloride) in malignant melanoma patients with liver metastases, the firm announces Nov. 1. "Our focus has shifted to potential filings for…acute myeloid leukemia based on our positive Phase III trial reported this summer, as well as partnering efforts for both Ceplene and our apoptosis compounds," Maxim says. Negative results for a confirmatory Phase III trial in advanced malignant melanoma were reported in September; the company said it would evaluate whether to pursue the indication (1Pharmaceutical Approvals Monthly Oct. 1, 2004, In Brief)...
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