Amerigen awarded US FDA's approval for generic mixed amphetamine salts, extended-release capsules
25 January 2019 -

Pharmaceutical business Amerigen Pharmaceuticals Limited revealed on Thursday the receipt of approval from the US Food and Drug Administration for the Abbreviated New Drug Application (ANDA) for the generic version of Adderall XR in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.

The company has received the US FDA's NDA approval for the generic version of Shire's Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.

In conjunction, the company's Amerigen Pharmaceuticals Inc US affiliate is currently selling an authorized generic version of Adderall XR, with a planned launch in the near future.

Additionally, the US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc, based in Lyndhurst, NJ.