US FDA approves two new chemopathy drugs by Strides subsidiary Onco Therapies

Bangalore: Strides Arcolab's  wholly owned subsidiary Onco Therapies today said that following US FDA approval for its Paclitaxel Injection USP, it will launch the project immediately through Pfizer in the US market.

It 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 and 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 is approximated $46 million.

Onco Therapies said it has received 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.

The company said it has also received tentative approval for Oxaliplatin Injection, which according to IMS data has a US market of approximately $1.4 billion.

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.

Paclitaxel and Oxaliplatin are part of the oncology portfolio licensed to Pfizer in January 2010 for the US market.