Teva Pharmaceuticals announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Mixed Amphetamine Salts ER (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate 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.
Mixed Amphetamine Salts ER will be available in 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg extended-release capsules.
For more information call (888) TEVA-USA or visit www.tevausa.com