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Exubera filed in Europe; U.S. plans?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aventis and Pfizer are "working with [FDA] to determine the appropriate timing for submission of the Exubera [NDA] in the U.S.," according to Aventis. The firms announced submission of a marketing authorization application for their inhaled insulin product with the European Medicines Evaluation Agency March 4, for treatment of type 1 and 2 diabetes...

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