Ivax Corporation received final Marketing Authorization approval from the Medicine and Healthcare Products Regulatory Agency for fluticasone nasal spray. Fluticasone is the generic equivalent of Flixonase (known in the US as Flonase) and marketed by GlaxoSmithKline for the treatment of rhinitis.
Ivax' generic equivalent of this product has been developed for the UK by Ivax Research Inc. in the United States and is part of a worldwide development programme. This is the first generic approval for fluticasone in the UK and Ivax will be marketing this product immediately.
Annual UK sales of Flixonase are approximately $30 million. Ivax expects to pursue further approvals for this product across Europe, and has an ANDA for a generic equivalent of Flonase pending with the US Food and Drug Administration, a company release said.