Impax Laboratories, Inc, a specialty pharmaceutical company, announced that the US 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.

"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 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 maximise the value from this important product."

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.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The product has a boxed warning because amphetamines have a high potential for abuse. In addition, prolonged administration may lead to dependence and misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.