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

Five things for pharma marketers to know: Friday, August 22

Five things for pharma marketers to know: Friday, ...

Two new indications give Eliquis more juice, a new rule is making hydrocodone harder to get and the ALS Ice Bucket Challenge highlights a controversial aspects of drug discovery and ...

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.