Teva wins generic Famvir approval from FDA

Novartis’ Famvir is used to treat or shorten the duration of recurrent genital herpes.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained final US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) to market its generic version of Famvir (Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. made by Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ). Famvir is used to treat or shorten the duration of recurrent genital herpes. Teva has a 180-day exclusivity period for generic Famvir.

The brand product had annual sales of $200 million in the US in the twelve months through June 2007, based on IMS sales data.

Novartis filed a patent infringement suit against Teva in April 2005 over Famciclovir products. The US District Court for the District of New Jersey hearing is due to hear Novartis' motion for a preliminary injunction in this case on September 5, 2007. Both parties have agreed not to launch a generic Famciclovir product until the conclusion of the hearing.

Published by Globes [online], Israel business news - www.globes.co.il - on August 26, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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