Company to hold six-month exclusivity on 27, 36 and 54 milligram
dosage strengths of ADHD treatment
ST. LOUIS--(BUSINESS WIRE)--Dec. 31, 2012--
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
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 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
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
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.
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
Vice President Communications