Glenmark obtains FDA tentative nod for generic Ofev

Glenmark has received tentative approval from the Food and Drug Administration for nintedanib capsules in dosage strengths of 100 mg and 150 mg.

The medication is the generic of Boehringer Ingelheim’s Ofev.

It is used to treat people with idiopathic pulmonary fibrosis, with a chronic interstitial lung disease in which lung fibrosis continues to worsen, and to slow the rate of decline in lung function in people with systemic sclerosis‑associated interstitial lung disease — also known as scleroderma‑associated ILD.

Ofev capsules had a market value of approximately $1.6 billion for the 12 months ended April 2021, according to IQVIA.