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Teva Wins Generic Famvir Approval

August 27, 2007

After receiving tentative approval earlier this summer, Teva Pharmaceutical Industries announced last week that it has won final approval for its generic version of Novartis’ antiviral Famvir.

Teva had said it expected to receive final approval upon the expiration of the mandatory stay of approval associated with generic Famvir (famciclovir) patent litigation.

As the first company to file an abbreviated new drug application containing a Paragraph IV certification for this product, Teva has been awarded a 180 days of marketing exclusivity, the company said. Teva said it will market 125-, 250- and 500-mg tablets of generic Famvir, which is used for treating herpes.

Famvir had U.S. sales of approximately $200 million during the 12-month period that ended in June, Teva said, citing IMS Health data.