Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for terbinafine hydrochloride tablets, in a 250mg dose.
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Terbinafine HCl Tablets are the generic version of Novartis’ Lamisil tablets, which are used for fungal infections.
Terbinafine HCl tablets had US sales of approximately $685 million for the 12 months ending March 31, 2007, for the same strength, according to the company.
The product will be shipped immediately.