Inhaled Insulin Exubera Delayed One More Time

The FDA was supposed to announce it’s decision on the first inhaled insulin last Thursday. But, the FDA notified the companies that it is extending its original review period for Exubera(R) (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

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