Shilpa Medicare Gets US FDA Nod for Cancer Drug

Shilpa Medicare Monday said it has received approval from the US health regulator for Gemcitabine for injection, used for treatment of various types of cancers. The approved product is a generic equivalent of reference listed drug Gemzar. The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection USP in the strengths of 200 mg/vial and 1 g/vial, Shilpa Medicare said in a BSE filing. Gemcitabine for injection USP is used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. Quoting IQVIA MAT data for December 2018, Shilpa Medicare said, the US market for Gemcitabine for injection USP, 200 mg/vial and 1 g/vlal is approximately USD 11.7 million. – Business Standard