Sunday, October 30, 2005

ExuberaTM on Hold

Final FDA approval of the only inhalable insulin to receive backing by an FDA panel has been put off for at least three months. The marketing go-ahead was expected last week.

Pfizer, Sanofi-Aventis, and Nektar Therapeutics, developers of the system, were notified last Friday that the FDA wanted to conduct an extended review of their "technical chemistry data".


For Pfizer and Sanofi-Aventis press release:
Pfizer and Sanofi-Aventis Statement on Status of Exubera

For a news summary:
FDA Delays Decision on Inhalable Insulin