Richwood is to relaunch Adderall (mixed amphetamine salts) in the USA in March after the Food and Drug Administration approved its supplemental New Drug Application for the treatment of attention deficit and hyperactivity disorder (ADHD), narcolepsy and exogenous obesity.
Adderall, formerly marketed by Rexar as Obetrol, was withdrawn from the market in October 1994 following an FDA warning letter. Richwood obtained the drug through its acquisition of Rexar in 1994, and filed the sNDA for the drug in September 1995. Despite the approval for an obesity indication, Richwood has said it will not promote Adderall for this use.
In the ADHD market, Adderall will compete with Ciba's Ritalin (methylphenidate) and generic methylphenidate from Medeva's MD Pharmaceuticals. Another generic from Johnson Matthey is awaiting FDA approval. In addition, Abbott has two ADHD therapies on the US market, namely Cylert (pemoline) and Desoxyn (methamphetamine).
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