January 27, 2006
Pfizer retracts premature Exubera approval statement
Pfizer retracted a remark made by its chief executive this morning that Exubera was approved in the US.
In an interview on CNBC, Hank McKinnell said that the drug gained FDA approval. Pfizer shares rose in early trading after the premature announcement.
Pfizer subsequently issued a statement saying Exubera (inhaled human insulin powder) has been approved by the European Commission but has not yet been approved by the FDA.
“Pfizer regrets an incorrect statement it made to CNBC about the regulatory status of Exubera in the US and is correcting it with CNBC,” the company said.
The European Commission approved the drug yesterday, while the FDA user fee date is today.
According to a report in The Wall Street Journal Online, McKinnell said in a follow-up interview with CNBC that Pfizer expects a decision soon, and that the earlier, incorrect statement was due to a mistake in the company’s internal communications.
A Pfizer spokesperson was not immediately available for comment.