Generic Adderall XR Approved

Impax Laboratories announced that they have received approval from the U.S. Food and Drug Administration for the generic version of Adderall XR – dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules.

The medication will be available in the following presentations: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.

“With this approval, we are now in a position to provide our customers a continuity in supply of generic Adderall XR as we transition from our current inventory of the authorized generic version to supply from our ANDA product,” Fred Wilkinson, Impax president and CEO, said in a statement. “We anticipate that we will complete this transition during the second quarter of 2016 and now have the opportunity to maximize the value from this important product.”

This medication is not without controversy. In September 2014, the U.S. Justice Department announced that in order to settle “allegations of making false claims in the marketing of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR and other medications,” it would pay $56.5 million, according to a Reuters report.

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--Stephanie Vaccaro

Reference:

1. Impax Laboratories. Impax receives FDA approval for generic version of Adderall XR® (mixed salts of a single-entity amphetamine product) capsules, CII [press release]. www.prnewswire.com. 2016 Feb 17.