Wockhardt has received final approval from the US FDA for marketing 50 mcg nasal spray of fluticasone which is used in treatment of allergic rhinitis. Fluticasone nasal spray is the generic name for the brand Flonase marketed in the US by GlaxoSmithKline. The company will be manufacturing the nasal spray, developed in-house, at its facility in Morton Grove, Illinois, USA.
The total market for this product in the US is about $580 million and there are only three other generic versions of the product in the US. Fluticasone nasal spray is amongst the most widely used corticosteroids in treating allergic rhinitis.
Dr Habil Khorakiwala, chairman, said, “Wockhardt is amongst the few companies to have an approval for Fluticasone nasal spray. We have always endeavoured to develop and market products based on challenging technologies and this approval of a nasal spray is another step in that direction. The product involved development of complex precisely controlled formulation as well as the device for he spray. The regulatory approval also required us to conduct clinical trials.”