Zydus gets final USFDA nod to market Adapalene and Benzoyl Peroxide Topical Gel

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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (USRLD: Epiduo Forte).

Zydus said that a combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation and Benzoyl Peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off.

“The drug will be manufactured at the group's topical facility at Ahmedabad. Adapalene and Benzoyl Peroxide Topical Gel had a market size of USD 195 mn (as per IQVIA MAT April 22).
The group now has 315 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04,” Zydus said in a statement.


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