ExuberaTreatment for Diabetes Type 1, Diabetes Type 2
Pfizer and sanofi-aventis Statement on Status of Exubera
NEW YORK, October 28, 2005 -- 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.
Posted: October 2005
- Exubera Approved - Pfizer Inc - Treatment for Type 1 and Type 2 Diabetes in Adults - January 27, 2006
- BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study - September 21, 2005
- FDA Advisory Committee Recommends Approval of Exubera for Use in Adults With Type 1 and 2 Diabetes - September 8, 2005
- Pfizer and the Sanofi-Aventis Group Seek Approval to Market Exubera in the United States - March 2, 2005