Nintedanib Capsules Approval and Launch

PARSIPPANY, N.J., April 7, 2026 /PRNewswire/ -- Dexcel Pharma USA is pleased to announce that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic equivalent of OFEV^® (nintedanib) capsules¹. Nintedanib is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a serious and progressive lung disease. 

Doug Boothe, CEO of Dexcel Pharma USA, stated: "We are excited to bring Nintedanib Capsules to market, further strengthening Dexcel's  growing portfolio of specialty pharmaceutical products. This approval reflects our commitment to providing high-quality, accessible treatment options for patients. We look forward to working with our partners and customers to expand access to this important therapy." 

The product will be available through specialty pharmacy and established pharmaceutical distribution channels, helping to ensure reliable access for patients across the United States.

For more information, please visit www.dexcelpharmausa.com

About Dexcel Pharma USA

Dexcel Pharma USA is the U.S. subsidiary of Dexcel Pharma. Dexcel Pharma is the largest private pharmaceutical company in Israel, commercializing an extensive portfolio of branded and generic drugs. Our state-of-the-art R&D and manufacturing facilities enable us to develop and manufacture high-quality products while maintaining long-term partnerships across the value chain.

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SOURCE Dexcel Pharma USA