Zydus Lifesciences bags FDA final approval for Tavaborole Topical Solution

Zydus Lifesciences has won final approval from the US Food and Drug Administration (FDA) for Tavaborole Topical Solution, 5%.

The approved product is a generic version of Kerydin Topical Solution.

According to Zydus Lifesciences, Tavaborole topical solution has FDA approval for the treatment of fungal toenail infections.

The Indian pharma company will manufacture the drug at its topical manufacturing facility at Changodar, Ahmedabad.

As per IQVIA MAT February 2023, the annual sales of Tavaborole Topical Solution, 5% in the US was $3.1 million.

Zydus Lifesciences currently has 361 approvals and to date has filed more than 440 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.