Pharmaceutical and biotechnology firm Wockhardt today received a final approval from the US Food and Drug Administration (USFDA) for marketing 50 mcg nasal spray of Fluticasone, the company said in a release filed with the Bombay Stock Exchange (BSE).
The formulation is used for the treatment of allergic rhinitis, an inflammation of the mucous membrane of the nose due to viruses, bacteria or other irritants. Fluticasone is the generic name for the brand Flonase, marketed in the US by Glaxo Smithkline.
According to the release, the total market for this product in the US is about $580 million and there are only three other generic versions of the therapy in the US.
The regulatory approval requires the company to conduct trials as well, said Chairman Dr Habil Khorakiwala.
Wockhardt will be manufacturing the nasal spray at its facility in Morton Grave in Illinois with an in-house developed technology.
At around 1145 hours, the shares of Wockhardt were trading up 2.90% at Rs 304.60 per share on the BSE.