Impax receives FDA approval for generic version of Adderall XR capsules, CII
Company due to supply its ANDA product during the second quarter of 2016.
Impax Laboratories has announced that 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.
"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," said Fred Wilkinson, President and CEO of Impax. "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."
Mr Wilkinson concluded, "The approvals of our generic Adderall XR application and the mid-January approval of Emverm (mebendazole) extend these key franchises, while also providing additional opportunities to pursue growth within these product segments."
According to IMS Health (NSP), US 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.
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