FDA Approves NINTEDANIB — Sandoz Inc

# FDA Approves Sandoz's Generic Nintedanib, Expanding Competition in Pulmonary Fibrosis Market Sandoz Inc. has received FDA approval for its generic nintedanib esylate oral formulation (ANDA216915), introducing competition to the pulmonary fibrosis and idiopathic pulmonary arterial hypertension markets previously dominated by Boehringer Ingelheim's branded Ofev. The approval is expected to increase patient access through lower-cost alternatives while potentially pressuring pricing and market share for the originator brand.