Alembic Pharma gets U.S. FDA nod for generic chronic constipation drug
Alembic Pharmaceuticals has received U.S. FDA approval for its generic version of the chronic constipation drug Prucalopride. The drug is a therapeutic equivalent to Takeda's Motegrity and targets a $100 million market.
Why it matters
This approval allows for a more affordable generic alternative in the U.S. market, potentially lowering healthcare costs for patients with chronic idiopathic constipation.
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.
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