Lupin Receives Approval from U.S. FDA for Prucalopride Tablets

Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Prucalopride Tablets, 1 mg, and 2 mg. Prucalopride Tablets are bioequivalent to Motegrity® Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc. The product will be manufactured at Lupin’s Goa facility in India. Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity®) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).