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| |  FDA Approves Extended Release Methylin (Methylphenidate) for Attention Deficit Hyperactivity Disorder ST. LOUIS, MO -- May 16, 2000 -- Mallinckrodt Inc. announced that its Methylin(TM) ER 10 mg and 20 mg tablets have been approved for marketing in the United States by the Food and Drug Administration. Methylin ER (methylphenidate hydrochloride extended-release tablets, USP), an extended release formulation of Methylin (methylphenidate hydrochloride), is indicated for the treatment of attention deficit/hyperactivity disorder (ADHD). Methylphenidate, the active ingredient of Methylin, is the leading pharmacotherapy for the treatment of ADHD, with years of proven efficacy and safety. "Methylin ER adds two more dosing options to help physicians provide the right amount of control at the right time for the right patient," said Marco Polizzi, business director, ADHD Products. "Greater flexibility helps ensure patient compliance and better therapeutic outcomes." Mallinckrodt also offers an immediate release formulation of Methylin in 5 mg, 10 mg, and 20 mg tablets. Methylin ER has an eight-hour duration of action, although behavioral efficacy is assessed most accurately on an individual patient basis. The extended release formulation is a therapeutic option when dosing schedules are problematic or when children feel stigmatized by having to take medication at school. Among school-age children, ADHD is the most common neurobehavioral disorder and one of the most prevalent chronic health conditions, affecting an estimated 4 percent to 12 percent of the school-age population. Core symptoms include inattention, hyperactivity, and impulsivity, which may lead to school difficulties, academic underachievement, troublesome interpersonal relationships with family and peers, and low self-esteem. Methylin ER is an integral part of a total treatment program that typically includes psychological, educational, and social interventions to produce a stabilizing effect in children with ADHD. Mallinckrodt has made a commitment to education and support with its recent pamphlet, 7 Guidelines for Managing ADHD, which provides parents with facts on the disorder and strategies for raising healthy, well-adjusted children. "Comprehensive, individualized therapy gives children with ADHD the best chance for a more productive life," said Marc Rohman, product manager -- ADHD, "Individualized drug therapy means providing the lowest dose that will yield the desired duration of behavioral efficacy, and Methylin ER helps make this possible." Nervousness and insomnia are the most common adverse reactions to methylphenidate. Additional effects may include, but are not limited to, skin rash, loss of appetite, dizziness, and headache. Methylphenidate should not be used in children under six years of age. Chronic abusive use can lead to marked tolerance. Mallinckrodt's ADHD Business Group was established in 1999, when the company launched the first of its Methylin tablets in immediate release formulation. Also in 1999, Mallinckrodt signed an agreement with SmithKline Beecham to co-market Dexedrine(R) (dextroamphetamine sulfate), which is effective therapy for pediatric patients with ADHD. With these two products, Mallinckrodt has taken a position of leadership in the field of ADHD. Mallinckrodt Inc. is a global manufacturer and marketer of specialty medical products designed to sustain breathing, diagnose disease and relieve pain. Named one of America's most admired medical product and equipment companies by Fortune magazine, Mallinckrodt does business in more than 100 countries. In fiscal 1999, combined net sales were $2.6 billion for Mallinckrodt's respiratory, imaging and pharmaceutical product lines. The company's Pharmaceuticals Group is a basic supplier of raw material, or bulk pharmaceuticals, as well as a manufacturer of a growing line of generic form dosage products. Its bulk pharmaceutical product lines include acetaminophen, the active ingredient in many over-the-counter pain medications, and natural narcotics, or opiates, such as codeine phosphate, morphine sulfate, hydrocodone and oxycodone. Generic versions of dosage products include combinations of oxycodone or hydrocodone and acetaminophen. Related Link: Mallinckrodt Inc.
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