Glenmark Pharmaceuticals yesterday said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer, in the American market.
The Mumbai-based drug major has received tentative approval from the US Food and Drug Administration (FDA) to market the product in the strength of 100 and 150 mg, Glenmark Pharmaceuticals said in a statement.
The company’s product is the generic version of Boehringer Ingelheim Pharmaceuticals Inc’s Ofev capsules.
According to IQVIA sales data for the 12-month period ending April 2021, the Ofev capsules (100 mg and 150 mg) had achieved annual sales of around $1.6 billion.