Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited has received the US FDA approval for paclitaxel injection 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 US FDA. According IMS data, the US market for generic Paclitaxel approximated US$ 46 Million. The Company will launch the product immediately.
The company also received tentative approval for oxaliplatin injection which according to IMS data has a US market of approximately US$ 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.
Paclitaxel and Oxaliplatin are part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market. This 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.
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.