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Home Industry News GSK receives ‘complete response’ from FDA over Cervarix

GSK receives ‘complete response’ from FDA over Cervarix

19th December 2007

GlaxoSmithKline (GSK) has received a complete response letter from the US Food and Drug Administration (FDA) in relation to its application for the Cervarix cervical cancer vaccine.

The FDA’s Center for Biologics Evaluation and Research (CBER) issues a complete response letter when the review of a file is completed but questions still need to be answered before approval can be granted.

GSK has stated that it will work closely with the FDA to prepare its response, which the company hopes to submit as soon as possible.

Barbara Howe, vice-president and director of the North America Vaccine Department at GSK, recounted how the company had already started to address questions and take part in discussions with the FDA to finalise its responses.

“Our discussions with the agency continue to be positive and constructive and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market,” she confirmed.

GSK’s filed application includes safety, efficacy and immune response data from clinical trials involving almost 30,000 females aged from ten to 55 years.

Also this week, GSK has announced the publication of new data on Tykerb (lapatinib) plus Xeloda (capecitabine) for the treatment of HER2-positive breast cancer that has spread to the brain and had progressed on Tykerb alone.

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