Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market a generic version of CONCERTA ® (methylphenidate HCl) Extended-Release (ER) Tablets USP (CII) in 27, 36 and 54 mg dosage strengths. The company will launch Methylphenidate HCl ER Tablets in the 27 mg dosage strength immediately. Methylphenidate HCl ER Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Mallinckrodt believes it holds a separate 180-day exclusivity period for each of the 27, 36 and 54 mg dosage strengths, which begins upon commercial launch of each respective dosage strength. Mallinckrodt’s current plan is to have the 36 mg and 54 mg dosage strengths commercially available in the first calendar quarter of 2013. Mallinckrodt plans to submit a supplement to its approved abbreviated new drug application for the 18 mg dosage strength in the first calendar quarter of 2013. “This approval represents an important addition to our line of generic pharmaceutical products, and we look forward to providing an affordable treatment option to patients coping with ADHD,” said Mark Trudeau, President, Mallinckrodt. “We are pleased the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market." Mallinckrodt is the largest U.S. supplier of opioid pain medications and among the top 10 generic pharmaceuticals manufacturers in the U.S., based on prescriptions. Covidien announced in December 2011 that it plans to spin off Mallinckrodt into a stand-alone company, a process expected to be completed in mid-2013.
As a result of the FDA approval and continued good operational performance, Covidien is increasing the fiscal 2013 net sales guidance for the Pharmaceuticals segment from the previous range of 1% to 4% above 2012 to 3% to 6% above 2012. There are no other changes to Covidien’s previously announced 2013 guidance. More details will be provided on January 25, 2013, when the Company announces its first-quarter results.IMPORTANT RISK INFORMATION FOR METHYLPHENIDATE HCl ER TABLETS INDICATION Methylphenidate HCl ER Tablets are indicated for the treatment of ADHD in children 6 years of age and older, adolescents and adults up to the age of 65. IMPORTANT RISK INFORMATION DRUG DEPENDENCE Methylphenidate HCl ER Tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Methylphenidate HCl ER Tablets are contraindicated in patients:
- With a known hypersensitivity to the product or its components;
- With marked anxiety, tension, or agitation;
- With glaucoma;
- With tics or a family history or diagnosis of Tourette’s syndrome; and
- Using or within 2 weeks of using a monoamine oxidase inhibitor
Health care professionals should monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Healthcare professionals should monitor for aggressive behavior. Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Methylphenidate HCl ER Tablets may cause long-term suppression of growth; monitor height and weight at appropriate intervals in pediatric patients. Methylphenidate HCl ER Tablets also may cause gastrointestinal (GI) obstruction with preexisting GI narrowing. Hematologic monitoring (periodic complete blood count, differential and platelet counts) are advised during prolonged therapy. SEE FULL PRESCRIBING INFORMATION, INCLUDING ADDITIONAL IMPORTANT RISK INFORMATION ABOUT METHYLPHENIDATE HCl ER TABLETS, AT: www.mallinckrodt.com/WorkArea/DownloadAsset.aspx?id=2147483760 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 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business. Mallinckrodt, the Pharmaceuticals business of Covidien, is a vertically integrated leader in providing products used in diagnostic procedures and in the treatment of pain and related conditions. The company is the largest U.S. supplier, by prescription, of opioid pain medications and a leading manufacturer of active pharmaceutical ingredients. It is also the largest US supplier of the medical isotope technetium-99m and an industry leader in radiopharmaceuticals and contrast media and delivery systems. Sales in 2012 were $2.0 billion. Please visit www.mallinckrodt.com to learn more about our business. CONCERTA is a registered trademark of ALZA Corporation. 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 payors and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations and the Foreign Corrupt Practices Act, 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, 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 and environmental remediation costs. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the fiscal year ended September 28, 2012, and in subsequent filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.