HSP

Hospira Inc. (HSP) said Tuesday that its drug Docetaxel, a generic version of the Sanofi-Aventis SA (SNY, SAN.FR) cancer drug Taxotere and an important growth driver for Hospira, hasn't garnered final Food and Drug Administration approval as soon as hoped because the agency had product-label questions.

The generic drug has tentative approval, and on Nov. 15 Hospira said in a press release that the next item needed--the FDA's approval for the final drug label--was expected within 10 business days. But the FDA requested amendments to that labeling, which the company has submitted for approval, Hospira said Tuesday.

"While Hospira cannot predict the timing for conversion of its tentatively approved Docetaxel to final approval, Hospira continues to work closely with the FDA to expedite this matter," the company said in a filing with the Securities and Exchange Commission.

"Hopefully we'll get approval before the end of the year," Thomas Werner, Hospira's chief financial officer, added while speaking at a Piper Jaffray health-care conference Tuesday.

Werner noted that the FDA requested certain changes to the packaging insert and labeling, and said it appears the issue was created by Sanofi switching to a single-vial product with double the concentration from a prior two-vial version. A Hospira spokesman said there isn't an issue with the drug itself, which the company already sells outside the U.S.

J.P. Morgan analysts said this new development likely is "a more minor delay with approval still a matter of when, not if." But if U.S. approval for Hospira's "key growth driver for 2011" doesn't come this year as J.P. Morgan forecasted, the delay could knock about 10 cents off the firm's 2010 per-share earnings estimate of $3.55, analysts said.

Hospira said in October that its adjusted $3.40 to $3.45 per share earnings guidance for this year didn't include any contribution from Docetaxel or another generic cancer drug called Gemcitabine, although the company saw a chance both could launch domestically in November. It announced the launch of Gemcitabine--a generic version of the Eli Lilly & Co. (LLY) chemotherapy drug Gemzar--on Nov. 15.

Hospira shares recently traded down 0.6% to $55.95, but are up 9.7% on the year.

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

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