The announcement follows the U.S. Food and Drug Administration approval of Mallinckrodt's Abbreviated New Drug Application (ANDA) for oxycodone hydrochloride extended-release Tablets in 10mg, 20mg, 40mg and 80mg dosage strengths, which was obtained on July 24, 2008. Mallinckrodt's oxycodone hydrochloride extended-release (ER) tablets are the generic pharmaceutical equivalent to OxyContin(R).(1)
Covidien's Pharmaceutical Products business is the sixth largest generic drug manufacturer in the United States and is one of the fastest growing, with more than 100 million total prescriptions dispensed annually.(2)
"The launch of our oxycodone hydrochloride ER tablets is an important milestone that reinforces Covidien's commitment to developing products for pain management," added Bramlage.
As required by statute, the agreement is subject to review by the Federal Trade Commission and the Antitrust Division of the Department of Justice.
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 four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 42,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit www.covidien.com for more information