ANI Pharmaceuticals’ abbreviated new drug application for an oral suspension of indomethacin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ankylosing spondylitis, according to a report from Healio. The agent—a generic version of the nonsteroidal anti-inflammatory drug indocin—has received 180-day exclusivity through a competitive generic therapy designation. In addition to treating ankylosing spondylitis, indomethacin may be effective in patients with rheumatoid arthritis, osteoarthritis, and gouty arthritis. “We are happy to leverage the [competitive generic therapy designation] pathway to provide our customers and patients in need with expanded access to high-quality generics for limited competition products,” concluded Nikhil Lalwani, MBA, President and Chief Executive Officer of ANI Pharmaceuticals.
FDA Approval of Indocin Generic May Improve Access to Care
Conexiant
April 29, 2024