FDA Approves Generic Mixed Amphetamine Salts, Extended-Release Capsules

Amerigen announced its Abbreviated New Drug Application (ANDA) for a generic version of Shire's Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, has received final approval from the U.S. Food and Drug Administration.

Amerigen's U.S. affiliate, Amerigen Pharmaceuticals Inc., is currently selling an authorized generic version of this product and plans to launch Amerigen's ANDA product in due course.

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