USFDA okays Lupin Prucalopride Tablets for chronic idiopathic constipation
Mumbai: Global pharma major Lupin Limited has received a green light 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 for the treatment of chronic idiopathic constipation (CIC) in adults.
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc.
This product will be manufactured at Lupin’s Goa facility in India.
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).
This is the latest in a series of strategic developments for the company. Earlier this month, Lupin Limited signed a supply and license agreement with Sino Universal Pharmaceuticals (SUP), for the commercialisation of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule, in the Chinese market, for the treatment of chronic obstructive pulmonary disease (COPD).
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