Lupin's generic drug to treat ADHD symptoms gets USFDA approval
Mumbai: Lupin Limited announced on Tuesday that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for a generic version of Takeda’s Adderall XR Extended-Release Capsules.
The approved strengths include 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. This product, a Mixed Salts of a Single Entity Amphetamine formulation, is used in the treatment of attention-deficit hyperactivity disorder (ADHD).
The newly approved generic capsules will be manufactured at Lupin's Somerset facility in the United States.
“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.
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