Glenmark’s psoriasis drug receives FDA approval

Glenmark Pharmaceuticals obtains tentative ANDA approval for Calcipotriene Cream

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Calcipotriene is the therapeutic equivalent of Dovonex Topical Cream

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Calcipotriene Cream, 0.005 percent, the therapeutic equivalent of Dovonex Topical Cream, 0.005 percent of Leo Pharma A/S.

Dovonex is indicated for the treatment of plaque psoriasis. According to IMS Health sales data for the 12 month period ending March 2015, the Dovonex market achieved annual sales of approximately $92.8 million.

Glenmark will market this product upon receiving final approval of its Calcipotriene Cream, 0.005 percent ANDA. The patents listed in the Orange Book for Dovonex Cream are scheduled to expire on June 9, 2015.

The company's current portfolio consists of 97 products authorized for distribution in the US marketplace and 67 ANDA's pending approval with the US FDA.

 

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