Zydus Lifesciences gets USFDA’s final approval for Tavaborole Topical Solution

The United States Food and Drug Administration (USFDA) has given Zydus Lifesciences final approval to manufacture and market Tavaborole Topical Solution, 5%. (USRLD: Kerydin Topical Solution).
Tavaborole topical solution is prescribed for the treatment of fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). The medication will be produced at the group’s topical manufacturing facility in Changodar, Ahmedabad (India). Tavaborole Topical Solution, 5% had $3.1 million in annual sales in the United States (IQVIA MAT Feb. 2023). Since the beginning of the filing process in FY 2003-04, the group has received 361 approvals and filed over 440 ANDAs. Zydus Lifesciences (previously Cadila Healthcare) is an Indian pharmaceutical company.