Healthcare Industry News:  analgesia 

Biopharmaceuticals FDA

 News Release - November 20, 2009

FDA Extends Review of NDA for Exalgo

ST. LOUIS--(HSMN NewsFeed)--Covidien (NYSE:COV ), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo(TM) (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.

Neuromed Pharmaceuticals Ltd. and Covidien recently provided the FDA with supplemental information, which the agency determined to be a major amendment to the NDA. As a result, the FDA has extended its action date by three months to allow more time to review the application.

The proposed indication for Exalgo is once daily administration 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.

Covidien is the largest supplier of controlled pain medications in the United States, based on number of prescriptions. Neuromed is working to develop new and improved pain medicines.

“We are committed to providing patients with advanced pain medications and are optimistic that Exalgo will be approved,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “We will continue working with Neuromed and the Agency on securing approval for Exalgo.”

The U.S. rights to Exalgo were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June 2009. Under the agreement, Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all post-approval FDA regulatory filings. Neuromed will continue to work with Covidien to complete the clinical development and regulatory approval process.

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 in excess of $10 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, 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.


Source: Covidien

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