European drug regulator approves Strides' oncology injectible Oxaliplatin
16 Sep 2011
Bangalore: Onco Therapies Limited (OTL), wholly owned oncology subsidiary of Strides, says that it has been granted approval by the European Union for Oxaliplatin Injection 5 mg/ ml (10 ml, 20 ml and 40 ml).
The company said in a media statement, "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."
Oxaliplatin is amongst 37 drugs licensed to Pfizer on a semi-exclusive basis for sales in 17 European countries.
OTL's Oxaliplatin will be manufactured at the company's oncology complex in Bangalore.
This is the second European approval out of the 22 filings made by OTL in the year 2010 for products which have a combined market value of over $5 billion. OTL had applied for approval for the drug through a Decentralised Procedure (DCP).
As per the latest data available from IMS, the combined European market for Oxaliplatin stood at $312 million with four major players in the market.