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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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.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine 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).
Lupin Limited is headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals.
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