To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears Use of Adderall for Attention-Deficit/Hyperactivity Disorder URL: http://www.pslgroup.com/dg/2006A.htm Doctor's Guide February 21, 1996
FLORENCE, Ky., Feb. 21, 1996 -- The Richwood Pharmaceutical Company, Inc., a specialty pharmaceutical manufacturer and marketer, announced today that the U.S. Food and Drug Administration has approved the supplemental new drug application (NDA) submitted by Richwood for the use of Adderall(R)(mixed salts of a single-entity amphetamine) tablets in patients with Attention-Deficit/Hyperactivity Disorder (ADHD). Adderall is indicated for use in children 3 years of age and older with ADHD as an integral part of a total treatment program which typically includes psychological, educational and social measures. Adderall may improve attention span, decrease distractibility, and increase the ability to follow directions and finish tasks. The therapy may also improve the patient's ability to think before acting (decrease impulsivity), decrease hyperactivity and improve legibility of handwriting. In addition, aggression may decrease in youngsters with ADHD. "Those with ADHD need to have as many therapeutic options available as possible. We have found that many patients will go through 2 or 3 drugs before finding the medication that is most effective and best tolerated," stated Robert Hunt, M.D., a psychiatrist and researcher with the Center for Attention and Hyperactivity Disorders in Nashville. "Our experience with Adderall has been very positive. We are in the midst of conducting clinical trials that should give us some additional insight into use of this treatment. Adderall is available in 10 mg. and 20 mg. double-scored tablets, which offers precise dosage correlation with individual therapeutic needs. Adderall is generally well tolerated with few adverse reactions reported. The most frequently reported adverse reactions include anorexia, insomnia, stomach pain, headache, irritability and weight loss. As with most psychostimulants indicated for ADHD, the possibility of growth suppression and the potential for precipitating motor tics and Tourette Syndrome exists with Adderall treatment, and in rare cases exacerbations of psychosis have been reported. Since psychostimulants have a high potential for abuse, Adderall should only be prescribed as part of an overall treatment program for ADHD with close physician supervision. Adderall had previously been approved and marketed by another company under the name of Obetrol(R), indicated for exogenous obesity and ADHD. Richwood acquired the company, including the formulation and manufacturing rights to Obetrol, and renamed the product Adderall in 1994. Soon after the acquisition, the FDA determined that it needed to complete the review of the reformulated product application which was originally submitted in the 1970s. For the past year, while Richwood completed the supplemental NDA requested by the FDA, Adderall was only available under Investigational New Drug (IND) status to those patients who were already taking the product prior to November, 1994. This action allowed thousands of patients benefiting from Adderall to continue therapy. Richwood plans to have the NDA-labeled drug available in pharmacies nationwide by early March. Richwood is also providing free patient-education and physician counseling materials as part of their comprehensive program to enhance the treatment of ADHD. Adderall is one of the least expensive therapies for ADHD available in the United States. Richwood Pharmaceuticals, headquartered in Florence, Kentucky, is a specialty pharmaceutical company that markets and manufactures prescription pharmaceuticals and over-the-counter drugs. The company, founded in 1990, specializes in neuropharmaceutical products indicated for Attention-Deficit/Hyperactivity Disorder including Adderall and DextroStat(TM), and a specialty line of analgesic products for pain management. CONTACT: Doris Christelis of GTFH PR, 617-722-9706 --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.