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Glenmark Pharmaceuticals has received tentative approval from the US health regulator for generic Calcipotriene cream, used for the treatment of plaque psoriasis.
It said in a statement that Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Calcipotriene cream, 0.005 per cent.
The product is the therapeutic equivalent of Danish pharma firm Leo Pharma A/S Dovonex’s topical cream of the same strength, it added.
“Glenmark will market this product upon receiving final approval of its Calcipotriene cream, 0.005 per cent, abbreviated new drug application (ANDA),” the company said.
The patents listed for Dovonex cream are scheduled to expire on June 9, 2015, it added.
According to IMS Health sales data, for the 12-month period ending March 2015, Dovonex annual sales stood at around $92.8 million, it added.
Dovonex is indicated for the treatment of plaque psoriasis.
Glenmark currently has 97 products authorised for distribution in the US market and 67 abbreviated new drug applications (ANDAs) are pending approval from the USFDA, the company said.
Shares of Glenmark Pharmaceuticals were trading at Rs 907.80 per scrip, up 1.97 per cent on the BSE.
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