PR Newswire - Janssen Announces Launch of Authorized Generic for RISPERDAL
TITUSVILLE, N.J., June 30 /PRNewswire-FirstCall/ — Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced that it has launched an authorized generic version of RISPERDAL(R) (risperidone) through Patriot Pharmaceuticals, L.L.C.
Patriot is a subsidiary of McNeil-PPC. Both companies are a part of the Johnson & Johnson family of companies.
Janssen also announced that it will continue to make available branded RISPERDAL, which was first approved by the FDA in 1993.
RISPERDAL (risperidone) is indicated for the treatment of schizophrenia in adults and adolescents aged 13-17 years; and the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.
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RISPERDAL (risperidone) is indicated for the short-term treatment of Bipolar Mania in acute manic or mixed episodes associated with Bipolar I Disorder, either as monotherapy or in combination with lithium or valproate in adults; or as monotherapy in children and adolescents aged 10-17 years.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com/
Patriot Pharmaceuticals, LLC. is a subsidiary of McNeil-PPC, Inc. It markets and distributes authorized generic pharmaceuticals, including itraconazole, griseofulvin, ketoconazole, and cyclobenzaprine. Patriot is located in Plymouth Meeting, PA.
(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 the Company’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 December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
RISPERDAL(R) (risperidone) is used for the treatment of irritability associated with autistic disorder in children ages 5-17; the treatment of schizophrenia in adults; and the treatment of bipolar mania associated with Bipolar I Disorder in adults.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
The most common adverse reactions observed in all clinical trials with RISPERDAL occurring at a rate of at least 10% were somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
