Sun Gets FDA Tentative OK for Generic Gemzar

The FDA tentatively approved Sun Pharmaceutical’s ANDA for a generic version of Eli Lilly’s cancer drug Gemzar.

The approval comes roughly a week after Sun announced it had received final FDA approval for its ANDA to market a generic version of Roche’s Demadex (torsemide), which is indicated for the treatment of edema associated with congestive heart failure, renal disease or hepatic disease.

Sun’s generic Gemzar (gemcitabine HCl) injections are available in 200-mg and 1-g vials. Combined, these strengths have annual sales of approximately $680 million in the U.S., according to the company. It is approved in several cancer indications and has been available since 1996.