Alembic Pharma bags USFDA nod for idiopathic pulmonary fibrosis drug Pirfenidone
Pirfenidone Tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & 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.
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Pirfenidone Tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
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Pirfenidone Tablets, 267 mg and 801 mg have an estimated market size of US$ 548 million for twelve months ending December 2021 according to IQVIA.
Alembic has settled the case with Genetech and will launch its generic as per the terms of settlement. Alembic has a cumulative total of 167 ANDA approvals (144 final approvals and 23 tentative approvals) from USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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