Sun Pharmaceutical Industries Ltd. announced that US FDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co's Gemzar, gemcitabine injection.
These generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co's Gemzar injections available in two strengths: 200 mg and 1 g single use vial. These strengths of gemcitabine injections have annual sales of approximately USD 680 million in the US.
Gemcitabine is an anticancer, used singly or in combination with other anticancer agents.