Exubera FDA review pushed back, says Pfizer and sanofi-aventis

By Angela McDaniels

Seattle, Oct. 27 - Pfizer and sanofi-aventis said that the U.S. Food and Drug Administration has extending its original review period for Exubera inhalable insulin by three months to review additional technical chemistry data submitted by the companies.

EXUBERA is the product of joint-development program between the companies and uses a drug delivery method developed by Nektar Therapeutics.

In September, an FDA Advisory Committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes. The companies noted that the FDA is not obligated to follow the Advisory Committee's recommendation, but usually does so.

Pfizer is based in New York and develops pharmaceuticals.

Pharmaceutical company sanofi-aventis is based in Paris and focuses on research and development for cardiovascular disease, thrombosis, oncology, metabolic diseases, the central nervous system, internal medicine and vaccines.

Nektar Therapeutics is based in San Carlos, Calif. and develops drug delivery technologies.

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