Mallinckrodt Launches Additional Dosage Strengths of Generic CONCERTA® in
36 and 54 milligram dosage strengths of ADHD treatment now available
ST. LOUIS -- March 25, 2013
Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today
announced that it launched the 36 and 54 milligram (mg) dosage strengths of
Methylphenidate HCl Extended-Release (ER) Tablets USP (CII), generic version
of CONCERTA^®. These two dosage strengths will be available in addition to the
27 mg dosage strength. The 27 mg dosage strength was made available in
December 2012, when Mallinckrodt received approval from the U.S. Food and Drug
Administration (FDA) to manufacture and market the tablets in 27, 36 and 54 mg
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. The treatment is 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 36 and 54 mg dosage
strengths, which began upon commercial launch of each respective dosage
“The launch of these additional dosage strengths are important additions to
our line of generic pharmaceutical products and we look forward to providing
these affordable treatment options to patients coping with ADHD,” Mark
Trudeau, President, Mallinckrodt, said.
Mallinckrodt is the largest U.S. supplier of opioid pain medications and the
12^th largest generic pharmaceuticals manufacturer 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
IMPORTANT RISK INFORMATION FOR METHYLPHENIDATE HCl ER TABLETS
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
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 tics or a family history or diagnosis of Tourette’s syndrome; and
*Using or within 2 weeks of using a monoamine oxidase inhibitor
Serious adverse events, including sudden death, stroke and myocardial
infarction, have been reported in patients taking usual doses.
The most common adverse reaction (>5%) reported in children and adolescents
was upper abdominal pain. The most common adverse reactions (>10%) reported in
adults were dry mouth, nausea, decreased appetite, headache and insomnia.
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
Difficulties with accommodation and blurring of vision have been reported with
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:
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 controlled substance pain medications and a
leading manufacturer of active pharmaceutical ingredients. It is also the
largest U.S. 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.
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.
Manager, Media Relations
Senior Vice President, Communications
Coleman Lannum, CFA
Vice President, Investor Relations
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