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FDA approves Actavis ADHD drug

6/25/2012

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.



Actavis, whose parent company was recently acquired by Watson Pharmaceuticals, announced the approval of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, also known as mixed-amphetamine salts ER capsules.



The drug, approved in the 5-mg, 10-mg, 15-mg, 20-mg, 25-mg and 30-mg strengths, is a generic version of Shire Adderall XR. The branded drug and generic versions had sales of $1.99 billion during the 12-month period ended in March, according to IMS Health.




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