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Exubera Inhaled Insulin User Fee Deadline Is January 2006

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer and Sanofi-Aventis filed the Exubera NDA March 1; an early 2006 approval is based on a standard 10-month review. The companies expected to submit an NDA in 2001, but were delayed by pulmonary safety questions.

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