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FDA Postpones Exubera Verdict

The makers of an inhalable insulin (Exubera, Pfizer/Sanofi-Aventis) must wait 3 more months to learn the drug's fate as the Food and Drug Administration (FDA) examines new chemistry information.

An October 28 statement said the drugmakers received notification that the agency was "extending its original review period for Exubera... by 3 months to review additional technical chemistry data submitted by the companies."

Pfizer and Sanofi developed Exubera with Nektar Therapeutics as an alternative to insulin injections. In a 7–2 vote September 8, an FDA advisory committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes (DOC News, November 2005).

Several committee members had expressed apprehension about the lack of data on inhaled insulin's long-term effects.

Pfizer and Sanofi say they will continue to work with the FDA.

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