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Lupin Receives US FDA Approval for Generic Adderall XR Extended-Release Capsules

21 Nov 2024
Admin
News Article

Lupin Receives US FDA Approval for Generic Adderall XR Extended-Release Capsules

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for 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 USA, Inc. The product will be manufactured at Lupin’s Somerset facility in the US.

Drug Indication

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 paediatric patients 6 years and older.

Drug Annual Sales

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 US (IQVIA MAT September 2024).

About the Company: Lupin

Lupin Limited is a global pharmaceutical leader 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.