District Court Decision Received in CONCERTA(R) Patent Case
CONCERTA(R) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies. McNeil previously filed a Citizen’s Petition with the FDA requesting the Agency to apply additional bioequivalence metrics to ensure that the approval of any generic versions of CONCERTA(R) extended-release methylphenidate tablets are both bioequivalent and clinically equivalent to the innovator product.
IMPORTANT SAFETY INFORMATION
Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.
CONCERTA should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA; significant anxiety, tension, or agitation; glaucoma; tics, Tourette’s syndrome, or family history of Tourette’s syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA.
Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA. Your child’s healthcare professional should check height and weight often and may interrupt CONCERTA treatment if your child is not growing or gaining weight as expected.
Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA does not adversely affect your ability to engage in such activities.
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.
For full prescribing information, go to www.concerta.net.
Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition, which includes a variable attention span and/or hyperactivity or impulsivity. According to the National Institutes of Health (NIH), ADHD is one of the most common psychiatric disorders in childhood. It affects an estimated four million children and an estimated eight million adults in
About McNeil Pediatrics
McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), markets CONCERTA(R) for the treatment of children, adolescents and adults with ADHD in
CONCERTA(R) and OROS(R) are a registered trademark of ALZA Corporation.
Contacts: Media Investors ----- --------- Tricia Geoghegan: (609) 730-3746 Louise Mehrotra: (732) 524-6491 Sri Ramaswami (609) 647-8195 Lesley Fishman (732) 524-3922
SOURCE McNeil Pediatrics