Wockhardt has received final approval from the US health regulator to market generic Fluticasone nasal spray, used for treating allergic nasal inflammation, in the American market.
“The company has received final approval from the United States Food and Drug Administration (USFDA) for marketing 50 mcg nasal spray of Fluticasone which is used in the treatment of allergic rhinitis,” Wockhardt said in a statement today.
The company is launching the product immediately in the US market, it added.
“The product involved development of complex precisely controlled formulation as well as the device for the spray. The regulatory approval also required us to conduct clinical trials,” Wockhardt Chairman, Mr Habil Khorakiwala, said.
Fluticasone nasal spray is the generic name for Glaxo Smithkline’s Flonase, Wockhardt said.
The company claimed that according to IMS Health, the total market for the product in the US is about $580 million and there are only three other generic versions of the product in the United States. The company will be manufacturing the nasal spray at its US facility at Morton Grove, Illinois, it said.
Shares of Wockhardt were trading at Rs 304.50 in the afternoon trade on the BSE, up 2.85 per cent from the previous close.