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Strides Arcolab subsidiary Onco Therapies Ltd has received final approval from the US health regulator for its generic version of Oxaliplatin injection used for treating cancer.
The US Food and Drug Administration approval is for Oxaliplatin injection in strengths of 50mg/10ml and 100mg/20ml, the company said in a statement today.
“The company had in November 2011 received tentative approval from the USFDA 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,” it added.
A company usually makes a Para III filing when it does not have any plans to sell the generic drug until the expiry of the original patent, whereas a Para IV filing is made when it believes that its generic product does not infringe innovator’s patent.
Citing IMS data, Strides said the US market for generic Oxaliplatin is approximately $1.5 billion.
“Oxaliplatin is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch,” the company added.
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.
Strides’ scrip was trading at Rs 757.85 on the BSE in the afternoon trade, up 4.62 per cent from the previous close.
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