Alembic Pharma Gets USFDA Approval To Market Pirfenidone Tablets In U.S.
Alembic Pharma has received USFDA approval to market Pirfenidone tablets, used to treat a lung disease, in the American market.
Alembic Pharmaceuticals Ltd. has received approval from the United States Food and Drug Administration to market Pirfenidone tablets in the U.S. market.
The company has received final approval from USFDA for its abbreviated new drug application for Pirfenidone Tablets, 267 mg and 801 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product Esbriet Tablets, 267 mg and 801 mg, of Genentech Inc., according to a statement released on Tuesday.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis--a lung disease.
Alembic Pharma 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 intravenous certification, the Vadodara-based drugmaker said. "Alembic has settled the case with Genetech and will launch its generic as per the terms of the settlement," it added.
According to IQVIA, a health information technology and clinical research firm, Pirfenidone tablets -- 267 mg and 801 mg -- had an estimated market size of $548 million for the twelve months ending December 2021.