• 22 June, 2025

Glenmark Pharma receives tentative ANDA approval for Calcipotriene Cream

May 05, 2015 | Tuesday | News | By BioSpectrum Bureau

Glenmark Pharma receives tentative ANDA approval for Calcipotriene Cream

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

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.

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