Sun Pharma gets USFDA tentative approval for generic Gemzar? injection
Sun Pharmaceutical Industries Ltd has announced that USFDA 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.
Tags: Sun Pharma