Zydus Lifesciences bags USFDA nod for acne drug Isotretinoin
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg (USRLD: Absorica Capsules, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg).
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne.
Isotretinoin capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad.
Isotretinoin capsules had annual sales of USD 115.4 mn in the United States (IQVIA MAT March 2025). The group now has 427 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that the company had received final approval from the USFDA to market Dapsone Gel, 7.5%, (USRLD: Aczone Gel 7.5%).
Read also: Zydus Lifesciences bags USFDA nod for Dapsone Gel for acne treatment
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
