Protracted review period for Exubera

Share this article:
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.
Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.