Glenmark receives tentative US FDA approval for psoriasis drug
The company has been granted tentative approval for calcipotriene cream, 0.005% - the generic version of Dovonex cream, which registered an annual sales of $92.8 mn in the US
 "Glenmark receives tentative US FDA approval for psoriasis drug")
Glenmark Pharmaceuticals has received tentative approval for calcipotriene cream, 0.005% - the therapeutic equivalent of Dovonex topical cream manufactured by Leo Pharma – from the US Food & Drug Administration (US FDA)
Glenmark will market this product upon receiving final approval of its calcipotriene cream, 0.005% ANDA. The patents listed in the Orange Book for Dovonex cream are scheduled to expire on June 9, 2015.
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% ANDA. The patents listed in the Orange Book for Dovonex cream are scheduled to expire on June 9, 2015.
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.