Actavis Group today announced that it has received approval from the FDA to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII, (hereafter referred to as Mixed Amphetamine Salts ER Capsules), in all available strengths: 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg. Distribution of the product has commenced.
Adderall XR, and its generic equivalents, had US sales of approximately $1.99 billion for the 12 months ending March 31st, 2012, according to IMS Health.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said: “The approval of Mixed Amphetamine Salts ER Capsules offers a significant value to our customers and patients. With ADHD class medications experiencing shortages in 2012, this important product will offer value and supply to the marketplace.This approval also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.”