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HOSPIRA I : Hospira Announces U.S. Approval of Solution Version of Gemcitabine Injection

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08/05/2011 | 05:35pm CEST

LAKE FOREST, Ill., Aug. 5, 2011 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of gemcitabine injection, a solution form of the drug. The solution presentations include 200 mg, 1 gm and 2 gm with a concentration of 38 mg/ml. The oncology medication had U.S. sales of more than $750 million in 2010, led by Eli Lilly's Gemzar(®). Hospira expects to launch the product in early September.

Hospira is the first company to offer gemcitabine in a solution formulation for the U.S. market. The solution formulation is designed to improve pharmacist convenience and handling safety. Its concentration is the same as the reconstituted strength of the available "freeze-dried" form. The solution versions, however, eliminate the need for reconstitution, improving workflow.

"Hospira is excited to offer U.S. pharmacists a solution form of gemcitabine that reduces preparation time," said Thomas Moore, president, U.S., Hospira. "Hospira's generic gemcitabine solution gives the medical community access to a lower-cost, more convenient offering of this key oncology drug."

The approval follows the November 2010 launch of Hospira's lyophilized, or freeze-dried formulation, gemcitabine HCL for injection - the first 2 gm presentation of the product - and the July 2011 launch of the standard freeze-dried formulation in 200 mg and 1 gm presentations. With the previous launches of the freeze-dried presentations, the company will offer the generic oncology drug in a range of strengths and forms for use.

Hospira's specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as ADD-Vantage((TM)) drug delivery system and iSecure((TM)) prefilled syringes. Therapeutic segments include analgesia, anesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas. Hospira also has robust pipelines of both generic and biosimilar drugs.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness((TM)). As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.

Private Securities Litigation Reform Act of 1995 --
A Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the growth opportunities for generic specialty injectable products. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent Forms 10-Q, filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.

SOURCE Hospira, Inc.

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