Glenmark Generics Inc., USA (GGI), the US based subsidiary of Glenmark Generics Ltd (GGL), has received final approval from the US FDA for Calcipotriene ointment 0.005%. The ointment is indicated for the treatment of plaque psoriasis in adults.
Calcipotriene ointment was marketed by Leo Pharmaceuticals as Dovonex ointment from its approval in December 1993 through April 2007, when the product was discontinued due to commercial viability. The brand garnered peak sales of approximately USD 93 million in the calendar year 2006, according to IMS Health. Leo Pharmaceuticals still markets and distributes a line of Dovonex products including a cream and a topical solution.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.