Mumbai, July 28: Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Prucalopride Tablets, 1 mg and 2 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product , Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation in adults. Refer label for a detailed indication.
Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of US$ 100 million for twelve months ending March 2026 according to IQVIA.
Alembic has a cumulative total of 245 ANDA approvals from USFDA.