Mumbai, Mar 7 (UNI) Sun Pharmaceutical Industries Ltd today said it has received a tentative approval from US Foods and Drugs Administration (USFDA) for the company's Abbreviated New Drug Application (ANDA) for generic anti-cancer gemcitabine injection.
These generic gemcitabine injections, the therapeutic equivalents of Eli Lilly and Co's Gemzar injections, are available in two strengths: 200 mg and one g single use vial. These strengths of gemcitabine injections have annual sales of approximately USD 680 million in the US.
Gemcitabine is an anti-cancer, used singly or in combination with other anti-cancer agents, the company said in a statement.
UNI VK DB SG KN1405