Investors



  • FOR INFORMATION ON
    REPORTING CHANGES AND
    REVISED REVENUE GUIDANCE click here.


  • FOR GIVEN IMAGING
    ACQUISITION INFORMATION, click here.


  • FOR 2013 INVESTOR DAY MATERIALS,
    click here.


  • For Pharmaceuticals
    spin-off information,
    click here.


  • For tax basis information
    due to the Mallinckrodt spin,
    click here.


News Release

Printer Friendly Version View printer-friendly version
<< Back
FDA Extends Review of Exalgo(TM)
ST. LOUIS, Feb 16, 2010 (BUSINESS WIRE) -- Covidien (NYSE:COV) today announced that the U.S. Food and Drug Administration (FDA) has set a new action date of March 1, 2010, under the Prescription Drug User Fee Act (PDUFA) for the review of the New Drug Application (NDA) for Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets, (CII).

The latest rescheduling of the action date for Exalgo is the result of the FDA's decision to allow more time for its review of pending NDAs following the agency's recent weather-related closure. Please see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm200361.htm for the FDA's press release on the subject.

During the extended review process, Neuromed and Covidien will continue to collaborate to ensure any requests for information from the agency are addressed as quickly as possible.

Covidien is the largest supplier of controlled pain medications in the United States, based on number of prescriptions. Its development partner, Neuromed Pharmaceuticals Ltd., a wholly owned subsidiary of CombinatoRx, Incorporated, develops novel drug candidates with a focus on the treatment of pain and inflammation.

In June 2009, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into an asset purchase agreement with Neuromed for the U.S. commercialization rights to Exalgo. Under the agreement, Covidien is responsible for all commercialization activities for Exalgo, including marketing, sales and all post-approval FDA regulatory filings. Neuromed acquired the U.S. marketing rights to Exalgo from ALZA Corporation in April 2007. CombinatoRx and Neuromed merged on December 21, 2009.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

SOURCE: Covidien

Covidien
JoAnna Schooler, 314-654-3543
Director, Communications
Pharmaceuticals
joanna.schooler@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Coleman Lannum, CFA
508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Brian Nameth, 508-452-4363
Director
Investor Relations
brian.nameth@covidien.com