Impax Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.
According to IMS Health (NSP), U.S. brand and generic sales of mixed amphetamine sales capsules, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg were approximately $1.8 billion for the 12 months ending in November 2015.
