Nektar Reports on Pfizer and Sanofi-Aventis Statement on Status of Exubera PR, Friday October 28, 12:41 pm ET
SAN CARLOS, Calif.--(BUSINESS WIRE)--Oct. 28, 2005--Nektar Therapeutics (Nasdaq:NKTR - News) reported today that Pfizer and sanofi-aventis, a member of the sanofi-aventis Group, said today that the U.S. Food and Drug Administration has notified the companies that it is extending its original review period for Exubera® (insulin (rDNA origin) powder for oral inhalation) by three months to review additional technical chemistry data submitted by the companies.
In September, 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, but usually does so. Pfizer and sanofi-aventis continue to work closely with the FDA so that this important medicine can be made available for patients.
About Nektar
Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.
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