Protracted review period for Exubera
The FDA notified Pfizer and Sanofi-Aventis that it is extending the original review period for Exubera, the companies' experimental inhaled insulin product, by three months.
The period is being prolonged "to review additional technical chemistry data submitted by the companies," the firms said today in a statement.
The PDUFA (Prescription Drug User Fee Act) date of Oct. 27 has been changed to Jan. 27.
In September the FDA's Endocrinologic & Metabolic Drugs Advisory Committee voted 7-2 in favor of approving Exubera, which Pfizer and Sanofi-Aventis are developing with Nektar Therapeutics, despite concerns about potential adverse lung effects.