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Onco Therapies gets FDA nod for Oxaliplatin injection

13 August 2012 | Regulatory | By BioSpectrum Bureau

Onco Therapies gets FDA's nod for Oxaliplatin injection

Strides subsidiary Onco Therapies has received ANDA approval for Oxaliplatin injection

Strides subsidiary Onco Therapies has received ANDA approval for Oxaliplatin injection

Bangalore: Onco Therapies, a wholly owned subsidiary of Strides Arcolab (Strides), has received final ANDA approval for Oxaliplatin injection 50mg/10mL and 100mg/20mL.

The company, 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.

According to IMS data, 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.

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