New Delhi, Sep 30 : Onco Therapies Ltd, a wholly-owned arm of Strides Arcolab Ltd (Strides), today announced that it has received US Food and Drug Administration (FDA) approval for Paclitaxel Injection USP.
Paclitaxel, a chemotherapy drug, is used alone or with other drugs to treat ovarian cancer, breast cancer, non-small cell lung cancer and AIDS-related Kaposi's sarcoma.
It will launch the product immediately, the firm said in a statement.
The company also received tentative approval for Oxaliplatin Injection which according to IMS data has a US market of about 1.4 billion dollars.
Paclitaxel and Oxaliplatin are part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market.
Paclitaxel is among the products in the drug shortage list of the American Society of Health-System Pharmacists and the USFDA.
According IMS data, the US market for generic Paclitaxel approximated 46 million dollars.
It will launch the product immediately, the firm said in a statement.
The company also received tentative approval for Oxaliplatin Injection which according to IMS data has a US market of about 1.4 billion dollars.
Paclitaxel and Oxaliplatin are part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market.
Paclitaxel is among the products in the drug shortage list of the American Society of Health-System Pharmacists and the USFDA.
According IMS data, the US market for generic Paclitaxel approximated 46 million dollars.
--UNI
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