Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic product to treat acne in the American market.
The drug firm has received final approval from the US Food and Drug Administration (USFDA) for Isotretinoin Capsules USP (10 mg, 20 mg 30 mg and 40 mg), it said in a statement. Isotretinoin capsules are used to treat severe cystic acne that has not responded to other treatments.
The drug will be manufactured at Zydus’ formulation manufacturing facility in Moraiya, Ahmedabad. As per the IQVIA MAT data, Isotretinoin Capsules had annual sales of USD 165 million in the US.
As per the company filings, Zydus registered strong YoY growth driven by new launches and improvement in base business. On a sequential basis too, the business grew on a high base of the previous quarter. It received 20 new product approvals (incl. 3 tentative approvals) and launched 4 new products, filed 4 ANDAs during the quarter. As of August 11, 62 ANDAs were pending approval with the USFDA.
