Zydus Lifesciences bags USFDA nod for Dapsone Gel for acne treatment

Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD: Aczone Gel 7.5%).

Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).

Dapsone Gel, 7.5% had annual sales of USD 35.8 mn in the United States (IQVIA MAT March 24).

The group now has 395 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that Company had received final approval from the USFDA to market Tretinoin Cream USP, 0.1%, (USRLD: Retin-A Cream, 0.1%).

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