Teva announces final FDA approval for generic antifungal tablets
Will start marketing terbinafine hydrochloride, generic of Novartis' Lamisil, immediately
By TheMarkerTeva (TASE, Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for its generic version of antifungal tablets, Terbinafine Hydrochloride.
The approval relates to a 250 mg dose.
The drug is the generic equivalent of Novartis' antifungal agent Lamisil Tablets.
Shipment of this product will begin immediately, Teva stated.
Teva is not the only generic drugs company to launch a version of Lamisil. It was beat to the finish by Mylan Laboratories, which announced watchdog approval for its version on Friday.
The drug is not a small one: annual U.S. sales reached $685 million during the twelve months ending on March 31, 2007, according to IMS sales data.
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