Ortho-McNeil Pharmaceutical, Inc. Enters into Agreement with Watson Laboratories, Inc. for CONCERTA(R) Authorized Generic
Published: Nov 02, 2010
"The availability of an authorized generic version of CONCERTA that is both bioequivalent and clinically equivalent to the complex, extended-release innovator compound is particularly important -- and reassuring -- for patients with ADHD and their families," states Don Heald, PhD, Vice President Clinical Pharmacology, Neurosciences, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "It is also important for healthcare professionals who may consider prescribing a generic product for this condition."
In 2004, the affiliate of OMJPI that marketed CONCERTA at that time filed a Citizen Petition requesting generic versions of CONCERTA demonstrate a similar onset of efficacy and a similar duration of effect to the innovator product. The Citizen Petition, which remains under review by the Food and Drug Administration (FDA), is not impacted by this agreement. McNeil Pediatrics, a division of OMJPI, will continue to market the branded CONCERTA® product.
Under the terms of the agreement, OMJPI will manufacture and exclusively supply Watson with the authorized generic product, which will be available in 18mg, 27mg, 36mg, and 54mg formulations. Watson will market and distribute the product in the United States until the end of 2014.
CONCERTA is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies.
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.
CONCERTA contains methylphenidate, a Schedule II controlled substance under the Controlled Substances Act.
For full prescribing information, go to www.concerta.net.
Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is headquartered in Titusville, New Jersey.
McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of children, adolescents, adults and healthcare professionals through the development of therapies specifically formulated for children, adolescents and adults. McNeil Pediatrics is a leader in the treatment of ADHD and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, N.J.
CONCERTA® and OROS® are registered trademarks of ALZA Corporation.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Ortho-McNeil-Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ortho-McNeil-Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.