NEW DELHI: Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to market Adapalene and Benzoyl Peroxide topical gel, used to treat acne, in the American market.
The drug firm has received final approval from the US Food and Drug Administration (USFDA) to market the product, it said in a statement. 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, Zydus Lifesciences noted. As per IQVIA MAT April 22 data, Adapalene and Benzoyl Peroxide Topical Gel had a market size of USD 195 million in the US.
Zydus Group now has 315 approvals and has so far filed over 420 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, the drug firm said. Shares of the drug firm were trading 2.28 per cent down at Rs 356.35 apiece on the BSE.