Pharmaceutical giant Lupin has announced receiving approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Mixed Salts of Single-Entity Amphetamine Extended-Release Capsules. The approval includes doses of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, which are generic equivalents of Takeda Pharmaceuticals’ Adderall XR.
The newly approved medication, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules, is prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six and above.
Manufactured at Lupin’s Somerset facility in the U.S., the product expands the company’s portfolio in the central nervous system (CNS) therapeutic area. Commenting on the achievement, Lupin stated that this marks a significant step in offering cost-effective treatment options to patients in need.
The reference-listed drug (RLD), Adderall XR, has an estimated annual market size of USD 865 million in the U.S., according to IQVIA MAT data for September 2024. With this approval, Lupin is poised to enter the competitive ADHD market, offering patients an affordable alternative to the branded medication.
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