New Delhi: Glenmark Pharmaceuticals on Tuesday said it has received final approval from the United States health regulator for its generic Fluticasone propionate lotion used in treating skin pain and itching caused by eczema.
Glenmark Generics Inc is the US subsidiary of the Glenmark Generics Ltd.
Glenmark Generics Inc has been granted final approval by the United States Food and Drug Administration (USFDA) for their abbreviated new drug application (ANDA) for Fluticasone propionate 0.05% lotion, Glenmark said in a filing to the Bombay Stock Exchange (BSE).
Fluticasone propionate 0.05% lotion by Glenmark is generic version of Nycomed’s Cultivate lotion.
Nycomed had filed a patent infringement suit in the US district court, of New York in December 2008, challenging Glenmark’s ANDA for Fluticasone propionate lotion.
Glenmark said that in the event the company ‘successfully challenges’ Nycomed’s patent it will be entitled to 180 days exclusivity period.
“The company believes it is the first applicant to have filed an ANDA for this product with a paragraph IV certification,” it added.
According to IMS health sales data ending December 2010 Cultivate lotion achieved annual sales of nearly $48 million in the American market, Glenmark said.
Shares of Glenmark Pharmaceuticals were on Tuesday trading at Rs296.25 in the late afternoon trade on BSE, down 0.52% from its previous close.