Ivax Receives Final Approval for Fluticasone Nasal Spray in UK
Ivax has received final marking authorization approval from the Medicine and Healthcare Products Regulatory Agency for fluticasone nasal spray.
Fluticasone is the generic equivalent of Flixonase (known in the U.S. as Flonase) and marketed by GlaxoSmithKline for the treatment of rhinitis. Ivax's generic equivalent of this product has been developed for the UK by Ivax Research in the U.S. and is part of a worldwide development program.
This is the first generic approval for fluticasone in the UK, and Ivax will be marketing this product immediately, the company said. Annual UK sales of Flixonase are approximately $30 million. Ivax expects to pursue further approvals for this product across Europe, and has an abbreviated new drug application for a generic equivalent of Flonase pending with the FDA.