Diabetes Research

U.S. FDA extends review period for Exubera by 3 months

Published in Drug Week, December 2nd, 2005

Nektar Therapeutics (NKTR) reported that Pfizer and sanofi-aventis, a member of the sanofi-aventis Group, said that the U.S. Food and Drug Administration (FDA) has notified the companies that it is extending its original review period for Exubera (insulin [rDNA origin] powder for oral inhalation) by 3 months to review additional technical chemistry data submitted by the companies.

Earlier, an FDA advisory committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes. FDA is not obligated to follow the advisory committee's recommendation. Pfizer and sanofi-aventis continue to work closely with the FDA so that this important...

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Source: Drug Week (2005-12-02)

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