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Roxane gets FDA approval for generic Lamisil

Roxane Laboratories has received approval for its abbreviated new drug application for terbinafine hydrochloride tablets, 250mg, by the FDA.

The product, which is for the treatment of fungal infections, is available in bottles of 30 tablets and 100 tablets for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories’ terbinafine hydrochloride tablets, 250mg are AB rated to Novartis’ Lamisil.