Generic Adderall tablets approved

Published: 18-Apr-2002
Regulatory


US generic drug manufacturer Barr Laboratories has received approval from the US FDA for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetimine sulfate, amphetamine sulfate tablets, 5mg, 10mg, 20mg and 30mg. This mixed salts of a single-entity amphetamine product is an AB rated generic equivalent of Shire Richwood's Adderall tablets for stabilising ADHD in children. The company expects to be the first to market generic Adderall and plans to launch the product immediately. Current annual sales are approximately US$345m (€391m).

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