-- Provides update on docetaxel approval status --
LAKE FOREST, Ill., Nov. 15, 2010 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced it has launched a two-gram vial of gemcitabine hydrochloride for injection. The oncology medication is a generic version of Eli Lilly's Gemzar®, which posted 2009 U.S. sales of nearly $750 million for the full range of standard presentations.
Hospira's gemcitabine is approved by the U.S. Food and Drug Administration (FDA) for treatment of a variety of cancers. Hospira will be the first and only company to offer gemcitabine in a two-gram vial for 180 days from the date of launch based on market exclusivity earned as the first company to file for this generic presentation of the drug.
"Hospira heard calls from physicians and pharmacists for a larger presentation of gemcitabine in line with dosing practices, and we've met their needs," said Thomas Moore, president, U.S., Hospira. "With this launch, we've expanded the availability of generic oncology offerings and added additional convenience for the medical community."
Regarding its filing for docetaxel, a generic version of Sanofi-Aventis's oncolytic Taxotere®, Hospira announced that its final label is pending FDA approval, which is expected at any time, but no later than within 10 business days.
"While Hospira cannot predict the timing for conversion to final approval, we have been working closely with the FDA and are confident the Agency understands the importance of delivering new, high-quality, cost-effective generic drugs to U.S. citizens as quickly as possible to increase patient access to treatment options and reduce the overall costs of healthcare," said Moore.
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™ drug delivery system and iSecure™ 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.
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. 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 13,500 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 and the expected timing of FDA approval. 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.