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The FDA has approved marketing authorization for generic antifungal drugs
Zydus Worldwide DMCC has received final approval from the US Food and Drug Administration (FDA) to market the product
Zydus Lifesciences said its subsidiary has received approval from the US health regulator to market antifungal Efinaconazole Topical solution.
Zydus Worldwide DMCC has received final approval from the US Food and Drug Administration (FDA) to market the product, the drug firm said in a regulatory filing.
Efinaconazole is an 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 in Ahmedabad.
As per IQVIA data, Efinaconazole topical solution had annual sales of $292 million in the US.