Zydus Life gets final USFDA approval for topical acne treatment gel

The drug maker has received final approval from the US drug regulator to market Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (USRLD: Epiduo Forte).

"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," Zydus Lifesciences said in a statement on Tuesday.

Adapalene and Benzoyl Peroxide Topical Gel had a market size of $195 million (as per IQVIA MAT April 22).

The drug will be manufactured at group's topical facility at Ahmedabad. 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 Lifesciences (formerly known as Cadila Healthcare), a leading Indian pharmaceutical company is a fully integrated, global healthcare provider.

Zydus Lifesciences reported 41.5% fall in consolidated net profit to Rs 397.4 crore on a 5.3% increase in total income from operations to Rs 3,863.8 crore in Q4 FY22 over Q4 FY21.

Shares of Zydus Lifesciences rose 0.47% to Rs 364.65 on Monday.

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