Impax announced that the 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, the generic version of Shire‘s Adderall XR.
Adderall XR is a Class II amphetamine indicated for attention deficit hyperactivity disorder (ADHD). These agents block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Impax’s Mixed Amphetamine Salts product will be available as 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg strength extended-release capsules. The transition from the company’s current inventory of authorized generic versions to supply from their ANDA product is expected to completed during the second quarter of 2016.
For more information call (215) 558-4300 or visit ImpaxLabs.com.