FDA Approves Generic Version of Adderall XR

The FDA has approved Impax Laboratories’ abbreviated new drug application (ANDA) for generic Adderall extended-release (XR) capsules.

The FDA’s nod was for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsules in the following doses: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.

Adderall may be used to treat patients with attention-deficit/hyperactivity disorder.

“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, in a press release. "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."

The US brand and generic sales of mixed amphetamine sales capsules totaled $1.8 billion for the fiscal year ending in November 2015, according to IMS Health.

The product has a boxed warning about its high potential for abuse. In addition, patients who take Adderall for a prolonged amount of time may develop dependence or misuse the product.

In adults, the most common adverse effects associated with generic Adderall XR are dry mouth, loss of appetite, insomnia, headache, and weight loss.

In children aged between 6 and 12 years, the most frequent adverse effects include insomnia, abdominal pain, and nausea.