USFDA grants tentative approval to Sun Pharma's generic anti-cancer injection Gemzar
07 Mar 2008
The USFDA has granted tentative approval to Sun Pharmaceutical's abbreviated new drug application (ANDA) for its generic version of Eli Lilly's gemcitabine injection, Gemzar.
Thee generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co's Gemzar injections available in two strengths: 200mg and 1gm single use vial.
These strengths of gemcitabine injections have annual sales of approximately $680 million in the US.
Gemcitabine is an anticancer, used singly or in combination with other anticancer agents.
It is indicated for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
