HSP

Hospira Inc. (HSP) has pushed out the expected U.S. approval timeline for its drug Docetaxel, a key new product and a generic version of the Sanofi-Aventis SA (SNY, SAN.FR) cancer drug Taxotere, to the end of the first quarter.

The generic drug-maker previously hoped it launch the drug by late last year, but hasn't been able to secure final approval from the Food and Drug Administration. Chief Executive Chris Begley said the company is confident there is no product issue, but rather it just needs to clear an administrative hurdle.

"We are frustrated regarding the pace of approval," Begley said on a conference call with analysts Wednesday, following Hospira's fourth-quarter earnings release.

He said he's personally involved in the effort to get Docetaxel approved, and that "this is a top priority for us." The company said its guidance for the new year, which includes lower earnings than Wall Street expected, assumes approval late in this quarter.

Shares of the Lake Forest, Ill., company recently traded down 8.1% to $50.60, hurt by the guidance disappointment as well as softer fourth-quarter sales and earnings than analysts surveyed by Thomson Reuters expected. The company has been stung by an increase in back orders for its specialty injectable drugs and a voluntary hold on shipments of certain infusion pumps due to an alarm-failure issue.

Docetaxel has had tentative FDA approval, and on Nov. 15 Hospira said it anticipated FDA approval for the final drug label within 10 business days. That outlook was delayed when the FDA requested amendments to that labeling, but Hospira had still hoped it would gain approval by year-end.

J.P. Morgan has called the drug a "key growth driver for 2011."

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

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