Onco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab Ltd, has announced that it has received the US Food and Drug Administration approval for Paclitaxel injection and tentative nod for Oxaliplatin injection.
Paclitaxel and Oxaliplatin are part of the oncology portfolio licensed to Pfizer in January 2010 for the US market.
The company expects to launch the product immediately in the US market and according to IMS (a pharmaceutical intelligence and market research company) data, market size for generic Paclitaxel is about $46 million.
“Tentative approval for Oxaliplatin injection also has been got and IMS data estimate the size of US market is $1.4 billion. While other generic companies approved for this product are expected to launch the product in August 2012, Strides will issue further updates on this product in April 2012,” release said.
Paclitaxel is a chemotherapy drug to be used alone or with other drugs to treat ovarian cancer, breast cancer, non-small cell lung cancer and AIDS-related Kaposi's sarcoma. Whereas 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 company in a release said Paclitaxel injection is approved for USP, 6 mg/ml packaged in 30 mg/ml, 100 mg/16.7 ml and 300 mg/50 ml multiple dose vials.
Paclitaxel is among the products in the drug shortage list of the American Society of Health – System Pharmacists and the USDFDA.