Trade Resources Industry Views Actavis Group Has Gained FDA Approval to Market Dextroamphetamine Saccharate

Actavis Group Has Gained FDA Approval to Market Dextroamphetamine Saccharate

Actavis Group has gained FDA approval to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII (Mixed Amphetamine Salts ER Capsules).

The Mixed Amphetamine Salts ER Capsules are all available in 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg strengths.

According to IMS Health, Adderall XR, and its generic equivalents, had US sales of approximately $1.99bn for the 12 months ending 31 March 2012.

Actavis CEO Doug Boothe said the approval of Mixed Amphetamine Salts ER Capsules offers a significant value to the company's customers and patients.

"With ADHD class medications experiencing shortages in 2012, this important product will offer value and supply to the marketplace," Boothe added.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-actavis-generic-adderall-xr-cii-260612
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FDA approves Actavis generic Adderall XR CII