Dexcel Pharma USA, a subsidiary of Israeli pharmaceutical company Dexcel Pharma, announced on Tuesday that it has received final approval from the US 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) capsules.
Nintedanib is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a serious and progressive lung disease.
Dexcel said that the product will be available through specialty pharmacy and established pharmaceutical distribution channels, helping to ensure reliable access for patients across the United States.
OFEV is a brand of Boehringer Ingelheim International GmbH.
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