Teva Tentatively OK’D on Generic Gemzar

The Israeli drug firm Teva said Tuesday it has won tentative U.S. approval of a generic version of Eli Lilly’s Gemzar injectable cancer drug.

The company said full approval of the gemcitabine injection, 200 mg, must await the outcome of the patent litigation with Lilly that is ongoing in the U.S. District Court for the Southern District of Indiana.

Teva will have final approval to market generic Gemzar upon either a favorable decision in the case, or expiration of the mandatory stay of approval in July 2008, whichever comes first.

Lilly reported first-quarter revenues from worldwide sales of Gemzar of $377 million, an 11 percent jump from the first quarter of 2006.