Onco Therapies, a wholly-owned subsidiary of Strides Arcolab, has received final ANDA approval for Oxaliplatin injection 50mg/10mL and 100mg/20mL. The company had received tentative approval from US FDA in November 2011 based on a para III filing. This approval was later converted to a Para IV filing based on which USFDA has now granted final approval.
According to IMS data, the US market for generic Oxaliplatin is approximately $ 1.5 billion. Oxaliplatin is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch.
Oxaliplatin is a chemotherapy drug used to treat advanced cancer of the colon and rectum. It is used in combination with other medications to slow or stop cancer cell growth.
EP News Bureau