Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for its generic formulation of Takeda’s Adderall XR.
“Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg to market a generic equivalent of Adderall XR Extended-Release Capsules, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, of Takeda Pharmaceuticals U.S.A., Inc. The product will be manufactured at Lupin’s Somerset facility in the US,” the company said in a statement.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules are indicated for the treatment of attention deficit hyperactivity disorder in adults and pediatric patients 6 years and older, it added.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, extroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules (RLD Adderall XR) had estimated annual sales of USD 865 million in the U.S. (IQVIA MAT September 2024), it stated.
