HAYWARD, Calif. — Impax Laboratories Inc. has received Food and Drug Administration approval for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, mixed amphetamine product used for the treatment of attention deficit hyperactivity disorder (ADHD).
Impax said Wednesday that its mixed amphetamine product, a CII controlled substance, comes in dosages of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg and is a generic version of Adderall XR from Shire.
“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,” stated Fred Wilkinson, president and chief executive officer 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.”
U.S. branded and generic sales of mixed amphetamine capsules (5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg) totaled about $1.8 billion for the 12 months ended in November 2015, according to IMS Health data reported by Impax.
“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,” Wilkinson added.