FDA Approves Nintedanib Capsules for Idiopathic Pulmonary Fibrosis Treatment
Dexcel Pharma USA has announced the approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (FDA) for Nintedanib Capsules, 100 mg and 150 mg. These capsules are the generic equivalent of OFEV® and are indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a serious and progressive lung disease. Doug Boothe, CEO of Dexcel Pharma USA, expressed excitement about the approval, emphasizing the company's commitment to providing high-quality, accessible treatment options. The product will be available through specialty pharmacy and established pharmaceutical distribution channels, ensuring reliable access for patients across the United States.