New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), 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 (CIC) 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 (225 final approvals and 20 tentative approvals) from USFDA.
