Glenmark Pharmaceuticals gets FDA approval for Nintedanib Capsules

Glenmark Pharmaceuticals Ltd said that it has secured tentative approval from the US Food and Drug Administration (FDA) for Nintedanib Capsules, 100mg, and 150mg.

Nintedanib Capsules is the generic version of Ofev Capsules (nintedanib), 100mg and 150mg, owned by Boehringer Ingelheim Pharmaceuticals. Ofev is approved to be used in patients with idiopathic pulmonary fibrosis (IPF), chronic interstitial lung disease, and systemic sclerosis-associated interstitial lung disease.

As per sales data from IQVIA, for the 12-month period ending April 2021, the Ofev Capsules, 100mg, and 150mg market registered nearly $1.6 billion in annual sales.

Glenmark Pharmaceuticals gets FDA tentative approval for Nintedanib Capsules. Photo courtesy of Free-Photos from Pixabay.

The current portfolio of Glenmark Pharmaceuticals has 172 products authorized for distribution in the US along with 44 pending approvals of abbreviated new drug applications (ANDAs) with the FDA.

Earlier this month, Glenmark Pharmaceuticals had bagged final approval from the FDA for Theophylline Extended-Release Tablets, 300mg, and 450mg.