Covidien Announces Agreement with Purdue Pharma L.P. Enabling Launch of Oxycodone Hydrochloride Extended-Release Tablets.MANSFIELD, Mass. -- Covidien (NYSE NYSE
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BSX Bicycle Super-X (Cross) : COV), a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has reached an agreement with Purdue Pharma L.P. to end a patent infringement lawsuit between them. In connection with the agreement, Purdue has agreed to grant Mallinckrodt a royalty-bearing license to sell limited quantities of oxycodone hydrochloride extended-release tablets for a limited period of time ending in 2009. As a result, Mallinckrodt expects to begin selling oxycodone hydrochloride extended-release tablets before the end of September 2008.
The announcement follows the U.S. Food and Drug Administration approval of Mallinckrodt's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA
abbreviated new drug application ) 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 Ox·y·con·tin
A trademark for the drug oxycodone.
ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA)
Pharmacologic class: Opioid agonist [R].1
"Developing effective treatments for pain management is a major challenge, but the benefit oxycodone hydrochloride ER tablets have shown in patients is evident," said Chuck Bramlage, President, Pharmaceutical Products, Covidien. "We are pleased to make this treatment option available to meet patient needs."
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 to learn more about our business.
The full prescribing information for oxycodone hydrochloride extended-release tablets contains the following boxed warning:
Oxycodone hydrochloride extended-release tablets are an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.
Oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts.
n. can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing these Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
This Product is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs is needed for an extended period of time.
This Product is NOT intended for use as a prn analgesic.
The 10, 20, 40, and 80 mg Tablets ARE FOR USE IN OPIOID TOLERANT PATIENTS ONLY. This Product is contraindicated in patients with known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative re·sus·ci·tate
v. re·sus·ci·tat·ed, re·sus·ci·tat·ing, re·sus·ci·tates
To restore consciousness, vigor, or life to. See Synonyms at revive.
To regain consciousness. equipment), patients with acute or severe bronchial asthma or hypercarbia, or in any patient who has or is suspected of having paralytic ileus.
THESE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED TABLETS LEADS TO A RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for oxycodone hydrochloride extended-release tablets is available at: http://www.pharmaceuticals.mallinckrodt.com/_attachments/ PackageInserts/I071108 Oxy ER tablets.pdf (Due to the length of this URL URL
in full Uniform Resource Locator
Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. , it may be necessary to copy and paste To copy files from one location to another or to copy text and images from one document to another. All modern operating systems and applications have a copy and paste capability that is typically selected from an Edit menu. See cut and paste and Win Copy between windows. it into your Internet browser's URL address field)
1OxyContin[R] is a registered trademark of Purdue Pharma L.P.
2Source: IMS (1) See IP Multimedia Subsystem.
(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. NPA (1) (Numbering Plan Area) The Bellcore/Telcordia telephone area code system in use in the U.S., Canada, Alaska, Hawaii and islands in the Caribbean. See NPA code.
(2) (Network Professional Association, San Diego, CA, www.npanet. Plus, 2007
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