Wockhardt receives USFDA approval for Fluticasone nasal spray

NEW DELHI: Drug firm Wockhardt today said it 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 treatment of allergic rhinitis," Wockhardt said in a statement.

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 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 USD 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, Wockhardt said.

Shares of Wockhardt were trading at Rs 302.80 in morning trade on the BSE, up 2.28 per cent from previous close.