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Home » FDA Grants Mylan Tentative Approval for Generic Lamisil
FDA Grants Mylan Tentative Approval for Generic Lamisil
The FDA has granted tentative approval to Mylan Pharmaceuticals' abbreviated new drug application for terbinafine hydrochloride tablets in a 250-mg dose.
The product is a generic version of Novartis Pharmaceuticals' Lamisil tablets, which are used to treat certain types of fungus. Lamisil generated net sales of $528 million in 2004, according to Novartis' latest earnings report.
KEYWORDS Drug Pipeline Alert
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