Strides Arcolab's subsidiary Onco Therapies Limited has received final ANDA approval for Oxaliplatin Injection 50mg/10mL and 100mg/20mL.
The company had receive tentative approval from USFDA 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.
The Strides Arcolab Ltd. stock was trading at Rs.754.45, up by Rs.30.05 or 4.15%. The stock hit an intraday high of Rs.760.05 and low of Rs.729.
The total traded quantity was 0.49 lakhs compared to 2 week average of 0.40 lakhs.