Antifungal Tablets to Be Discontinued

Discontinuation not due to manufacturing, product quality, safety, or efficacy concerns
Discontinuation not due to manufacturing, product quality, safety, or efficacy concerns

The Food and Drug Administration (FDA) posted a discontinuation notice for Lamisil (terbinafine HCl; Novartis) tablets 250mg. 

The Company stated the permanent discontinuation was a business decision and is not due to manufacturing, product quality, safety, or efficacy concerns. The affected product has NDC 0078-0179-15 and is supplied as 250mg tablets in 30-count bottles. 

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Lamisil, an allylamine antifungal, is indicated for onychomycosis of the toenail or fingernail due to tinea unguium. It works by inhibiting the biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of squalene but not due to ergosterol deficiency. 

The 250mg strength tablets are expected to be available until approximately the end of April 2018.

For more information call (888) 669-6682 or visit FDA.gov.