Ranbaxy Pharmaceuticals Inc., New Jersey, USA, a wholly owned subsidiary of Ranbaxy Laboratories Limited, in an alliance with CorePharma LLC of Middlesex, New Jersey, have received US FDA approval to manufacture and market the fixed combination of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine, the company release said.
Sulfate and Amphetamine Sulfate Tablets in 5mg, 10mg, 20mg and 30mg dosage forms. This product has been deemed bioequivalent and, therefore therapeutically equivalent to the innovator product, Adderall, manufactured by Shire U.S. Inc.
CorePharma LLC is the holder of the ANDA for this generic version of Adderall, while Ranbaxy Pharmaceuticals Inc. has exclusive marketing and distribution rights to market this product in the U.S.
This combination drug is indicated for the treatment of Attention Deficit Disorder (ADHD), most commonly diagnosed as a childhood disorder. This product is an integral part of a total treatment program, which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional liability and impulsivity. ADHD affects approximately 3-5% of the elementary school age population in the United States, as well as 2-4% of adults.
Total sales for Adderall in the U.S. were approximately $350 million (IMS- MAT, December 2001), representing 8.9% of the ADHD market. The CorePharma ANDA approval for Adderall represents the second FDA approval granted to CorePharma LLC in 2002.
Ranbaxy plans to launch this product shortly, and it will become available in USA through wholesalers, distributors and retail pharmacies. This addition to the CNS category of products attests to Ranbaxy's commitment to the continued development and expansion to its therapeutically diverse product portfolio of generic products.