Onco Therapies gets FDA nod for Oxaliplatin injection

Bangalore: Onco Therapies, a wholly owned subsidiary of Strides Arcolab (Strides), has received final ANDA approval for Oxaliplatin injection 50mg/10mL and 100mg/20mL.

The company, in November 2011, received tentative approval from the USFDA 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.