 "Alembic Pharma gets USFDA approval to market Pirfenidone tablets")
Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Pirfenidone tablets used to treat lung disease in the American market.
The company said it has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, 267 mg and 801 mg, of Genentech, Inc, it added.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Alembic had previously received tentative approval for this ANDA. It was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drugmaker said.
"Alembic has settled the case with Genetech and will launch its generic as per the terms of the settlement," it added.
As per IQVIA, Pirfenidone tablets -- 267 mg and 801 mg -- have an estimated market size of USD 548 million for the twelve months ending December 2021.
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