Strides Arcolab’s wholly owned subsidiary Onco Therapies has received final ANDA approval for Oxaliplatin Injection 50mg/10mL and 100mg/20mL. The company had received tentative approval from USFDA in November 2011 based on a Para III filing. This approval was later converted to a Para IV filing based on which USFDA has now granted final approval.
Oxaliplatin is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch. 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.
According to IMS data, the US market for generic Oxaliplatin is approximately $1.5 billion.
Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.
Company Name | CMP |
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Sun Pharma Inds. | 1531.05 |
Dr. Reddys Lab | 6428.05 |
Cipla | 1482.30 |
Zydus Lifesciences | 1093.45 |
Lupin | 1637.60 |
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