Hospira Submits 510(k) Application to FDA for Symbiq™ Infusion System Modifications

-- Symbiq application represents one of the first based on new FDA draft guidance for 510(k) infusion pump submissions --

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Hospira, Inc.

Apr 04, 2011, 10:14 ET

LAKE FOREST, Ill., April 4, 2011 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), a leading provider of clinical information and medication delivery technologies, today announced that the company has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for modifications to the Symbiq™ infusion system. The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.

"With this submission complete, we are on track to meet our commitments for resuming new customer shipments of Symbiq infusion pumps and advancing the continuous evolution of one of the most innovative infusion platforms in the hospital today," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "As one of the first companies to file an application under the draft FDA guidance for infusion pumps, we are looking forward to continuing to work with the Agency through this new and innovative regulatory process."

The 510(k) submission to FDA for clearance of the Symbiq infusion system version 3.11 identifies modifications Hospira has made to further enhance the reliability of the infusion pump. In 2010, Hospira voluntarily placed shipments of the Symbiq pump on hold for customers, while the company finalized the proposed product upgrades. Hospira regularly communicates with current Symbiq customers regarding the status of the system modifications, and plans to upgrade all of the Symbiq infusion pumps currently in use once the FDA provides clearance. Hospira submitted the 510(k) application to the FDA on March 31, 2011.

Hospira is working closely with the FDA to ensure that the Symbiq submission follows all guidelines of the new 510(k) draft guidance for infusion pumps. The timeframe for FDA clearance of the Symbiq upgrade cannot be determined. However, Hospira has dedicated the resources necessary to resume new shipments of the Symbiq infusion system as soon as the 510(k) is cleared.

For more information about the FDA draft guidance for 510(k) infusion pump submissions, visit: Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (issued April 23, 2010).

About the Symbiq Infusion System

The Symbiq infusion system is a technologically advanced infusion device with several clinician-friendly features incorporated to help improve workflow and decrease medication errors. With Hospira MedNet™ safety software built into the device, Symbiq was the first general infusion system designed to provide additional medication-error protection by requiring users to select a drug library entry from the safety software for all drug delivery programs. Due to its highly sophisticated technology, Symbiq is one of the first devices to achieve I.V. clinical integration of infusion pumps with electronic health record systems, which can help decrease the number of steps and time required to program the infusion pump.

About Hospira

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 14,000 employees. Learn more at http://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 submission of the 501(k) application to the U.S. Food and Drug Administration (FDA) for the modified Symbiq infusion system. 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 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.