FDA Discusses Neuromed NDA Application for Exalgo

Covidien (NYSE: COV) today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.

Neuromed is seeking FDA approval for Exalgo for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA). The FDA had assigned a PDUFA date of November 22, 2009, to complete its review of the application.

Based on Neuromed’s recent discussions with the FDA, Covidien is working closely with Neuromed on the appropriate next steps to be taken regarding the NDA. Possible next steps include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2) of the FDCA, which utilizes different criteria to determine the basis for approval of a new drug candidate.

Covidien’s 2010 sales and operating margin guidance, provided on September 10, 2009, had not assumed any contribution from Exalgo.

Covidien will hold a conference call with investors tomorrow to discuss its fourth-quarter results and other matters. Call-in details are provided below.

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 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

CONFERENCE CALL AND WEBCAST

The Company will hold a conference call for investors on November 17, 2009, beginning at 8:30 a.m. ET. This call can be accessed three ways:

• At Covidien’s website: http://investor.covidien.com
• By telephone: For both “listen-only” participants and those participants who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 866-713-8310. For participants outside the U.S., the dial-in number is 617-597-5308. The access code for all callers is 91064338.
• Through an audio replay: A replay of the conference call will be available beginning at 11:30 a.m. on November 17, 2009, and ending at 5:00 p.m. on November 24, 2009. The dial-in number for U.S. participants is 888-286-8010. For participants outside the U.S., the replay dial-in number is 617-801-6888. The replay access code for all callers is 58107629.

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, fourth-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, issues related to our existing material weakness in accounting for income taxes 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.