Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received final approval from the United States Food and Drug Administration (USFDA) to market Efinaconazole Topical Solution, 10%. (US RLD: Jublia®).

Efinaconazole is an azole antifungal used for topical treatment of Onychomycosis of the toe nails due to Trichophyton rubrum and Trichophyton mentagrophytes. The drug will be manufactured at the group’s topical manufacturing facility at, Ahmedabad, India.

Jublia ® (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).

The group now has 317 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.