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Glenmark’s plaque psoriasis ointment calcipotriene (Dovonex) generic gets US approval

Friday, March 26, 2010, 20:22 This news item was posted in Industry category and has 0 Comments so far.

Indian generic firm Glenmark has received final approval for generic calcipotriene (Dovonex) ointment 0.005%, from the US FDA.

Calcipotriene 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.

Dovonex 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.

Recently, Glenmark received final ANDA approval for moexipril hydrochloride and hydrochlorothiazide tablets – the generic version of Schwarz Pharmaceuticals’ Uniretic.

Glenmark’s combination product of moexipril hydrochloride plus the diuretic hydrochlorothiazide is indicated for treatment of patients with hypertension.

Total sales for this combination during 12 month period ending December 2009 were USD 8 million, according to IMS Health.

In March Glenmark Generics Ltd won approval for the sale of generic ropinirole tablets in US.

Glenmark’s ropinirole hydrochloride is a generic equivalent of GlaxoSmithKline’s Requip tablets.

Requip is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease as well as the treatment of moderate to severe primary restless leg syndrome.

Ropinirole hydrochloride tablets reported $104 million in U.S. sales for the 12 months ending December 2009, according to IMS Health.

Glenmark’s current marketing portfolio consists of over 50 products authorized for distribution in the United States and it has nearly 50 ANDAs in various stages of the approval process with the U.S. FDA.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark).

Glenmark Generics has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. The company primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America.

Glenmark Generics supplies APIs to customers in approximately 65 countries, including the US, various countries in the EU, South America and India. Headquartered at Mumbai, India, has twelve manufacturing facilities in four countries and has five R&D centres.

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