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).
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