Generic drugmaker Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Prucalopride Tablets, 1 mg and 2 mg, used to treat chronic idiopathic constipation (CIC).
The approved ANDA is therapeutically equivalent to Takeda Pharmaceuticals USA Inc.’s reference-listed drug, Motegrity Tablets (1 mg and 2 mg), the company said on Tuesday.
Prucalopride Tablets had an estimated U.S. market size of $100 million for the 12 months ended March 2026, Alembic said citing IQVIA data. A serotonin-4 receptor agonist drug, it is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Published – July 28, 2026 10:34 pm IST
