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Novartis Pharmaceuticals Corporation and Celgene Corporation announced today that they received an approvable letter from the U.S. Food and Drug Administration (FDA) for Ritalin® LA (methylphenidate HCl extended-release capsules) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Ritalin® LA is a new, once-daily formulation of Ritalin® (methylphenidate HCl), which eliminates the need for a mid-day dose during school.
An approvable letter usually represents the final step before a product receives FDA clearance for marketing in the United States. Ritalin® LA is part of a broad partnering agreement between Novartis and Celgene Corporation (Nasdaq: CELG) encompassing the entire Ritalin® product line. Novartis licensed intellectual property rights related to the formulation of Ritalin LA from Celgene.
"Novartis is very pleased that the FDA has issued an approvable letter for Ritalin® LA and will work closely with the agency to finalize approval and make it available in the United States," said Larry Perlow, M.D., Senior Vice President and General Manager, Commercial Operations, Novartis Pharmaceuticals Corporation. "Ritalin® LA represents an important advance in ADHD treatment. It will offer physicians, patients and parents a new once-a-day option with the known safety and efficacy of Ritalin®, a product that has helped generations of people with ADHD. Ritalin® LA will be taken once daily, which will eliminate the need for children to take their medication during the school day."
Novartis submitted a new drug application (NDA) to the FDA on November 29, 2000. Ritalin® LA was shown to significantly improve ADHD symptoms. Overall, Ritalin® LA was considered effective, safe and well tolerated in clinical trials involving children aged 6 to 12 years.
"Ritalin® LA will offer physicians more flexibility in treating children with ADD and ADHD," said Sol J. Barer, Ph.D., President and Chief Operating Officer, Celgene Corporation.
ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior, and sustain focus in ways appropriate to his or her age. ADHD is the most studied childhood psychiatric disorder and is supported by a substantial body of scientific evidence. Scientific research indicates that ADHD may be related to deficiencies in certain neurotransmitters in the brain. Novartis supports only the proper diagnosis and treatment of ADHD.
Ritalin® LA will join the Novartis ADHD product portfolio, which includes Ritalin®, Ritalin® SR (methylphenidate HCl sustained-release tablets), and dexmethylphenidate HCl, a refined formulation of Ritalin®. Novartis licensed the worldwide (excluding Canada) marketing and development rights to dexmethylphenidate HCl from Celgene Corporation.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
The Novartis Group (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world. For further information please consult www.novartis.com.
Celgene Corporation, located in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of orally administered, small molecule drugs for the treatment of cancer and inflammatory diseases through gene regulation. Please feel free to visit the Company's web site at www.celgene.com.
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