FDA Approves PRUCALOPRIDE — Alembic Pharmaceuticals Inc.

Alembic Pharmaceuticals Inc. received FDA approval for its 6 mg prucalopride succinate tablets (ANDA 219234) on July 27, 2026, reportedly entering the market following a patent expiration for the branded formulation. This approval positions Alembic to offer a cost-effective alternative to existing therapies, leveraging import competition to capture market share in the treatment of chronic idiopathic constipation.