Zydus receives final USFDA approval for Efinaconazole Topical Solution

19 Jul 2022 , 09:17 AM

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).

As per the press release, Efinaconazole is an azole antifungal used for the topical treatment of Onychomycosis of the toenails 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.

At around 9:17 AM, Zydus Lifesciences was trading at Rs360.15 per share up by Rs1.95 or 0.54% from its previous closing of Rs358.20 per share on the BSE.