Trade Resources Industry Views GSK Has Submitted an Application Seeking Approval From EMA of a Variation for Votrient

GSK Has Submitted an Application Seeking Approval From EMA of a Variation for Votrient

GlaxoSmithKline (GSK) has submitted an application seeking approval from the European Medicines Agency (EMA) of a variation for Votrient (pazopanib).

The approval is for additional indication for Votrient as the maintenance treatment of women with Stage II-IV ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy.

GlaxoSmithKline Oncology R&D Head Dr Rafael Amado said, "This EU filing, the third for pazopanib in less than five years, confirms GSK's commitment to deliver our oncology pipeline. We are currently working on submission plans for other countries throughout the world."

Pazopanib is not approved or licensed anywhere in the world for the maintenance treatment of ovarian, fallopian tube or primary peritoneal cancer.

 

 

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/gsk-seeks-additional-indication-approval-for-votrient-from-ema-080813
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GSK Seeks Additional Indication Approval for Votrient From EMA