biospectrumasiaMarch 24, 2017
Tag: FDA , Clobetasol propionate
The United States Food and Drug Administration (USFDA) has given its nod for Clobetasol Propionate Ointment, used for the treatment of various skin conditions. The product has been manufactured by Glenmark Pharmaceuticals USA.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Clobetasol propionate is used for treating various skin disorders including eczema and psoriasis.
The approved is a generic version of Temovate Ointment (0.05 per cent), a product manufactured by Fougera Pharmaceuticals Inc.
The IMS Health sales data states that Temovate Ointment, 0.05 per cent had achieved annual sales of approximately $175.3 million at the end of last year.
The current portfolio of Glenmark comprises of 113 products authorized for distribution in the US marketplace and approximately 64 products approved by Abbreviated New Drug Application are lying pending with USFDA.
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