US FDA Approves Pulmonary Fibrosis Drug Developed by Alembic Pharmaceuticals


The company ‘Alembic Pharmaceuticals’ has announced that, the company has now received the final approval from the Food and Drug Administration (FDA) of the United States for the company’s Abbreviated New Drug Application (ANDA) for the pirfenidone tablets used for treating Pulmonary Fibrosis.

The approved ANDA has been therapeutically equivalent to the reference that has listed the drug product (RLD) known as Esbriet Tablets developed by the company Genetech, Inc. Pirfenidone has been used for the purpose of treating a certain lung disease called as the idiopathic pulmonary fibrosis (IPF) and the disease has been causing the lungs to get scarred and also becoming stiff, which is making it very hard for breathing.

According to IQVIA, the Pirfenidone Tablets are having an estimated market size of 548 million dollars for twelve months that is ending in December 2021, and the company has also settled the case with the company ‘Genetech’ and it is going to be launching as per the terms of the settlement.

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Alembic Pharmaceuticals are having a cumulative total of 167 ANDA approvals from the US FDA and the company has been a vertically integrated research and development pharmaceutical company and Alembic Pharmaceuticals manufactures and markets the generic pharmaceutical products all across the world.