Dexcel Pharma USA will launch nintedanib capsules for patients with progressive lung disease following final regulatory approval.
RT’s Three Key Takeaways:
- Generic Approval: Dexcel Pharma USA received final approval from the Food and Drug Administration for nintedanib capsules, the generic equivalent of OFEV.
- Disease Management: The medication is approved for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive respiratory condition.
- Distribution Channels: The capsules will be available through specialty pharmacies and established pharmaceutical distribution networks to support patient access in the US.
Dexcel Pharma USA received final approval from the FDA for its Abbreviated New Drug Application for nintedanib capsules, according to the company.
The capsules, approved in 100 mg and 150 mg strengths, are the generic equivalent of Ofev. Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF), which the company described as a serious and progressive lung disease.
“We are excited to bring Nintedanib Capsules to market, further strengthening Dexcel’s growing portfolio of specialty pharmaceutical products,” said Doug Boothe, chief executive officer of Dexcel Pharma USA, in a news release. “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 distributed through specialty pharmacy and established pharmaceutical distribution channels. The company stated this approach will help ensure reliable access for patients across the US.
The approval adds a generic option to the respiratory healthcare market for the management of IPF, a condition characterized by lung tissue scarring that makes it increasingly difficult to breathe.
