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Clinigen announces FDA decision on Totect
StockMarketWire.com
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Clinigen Group, the global pharmaceutical and services company, announced that the FDA has granted approval to broaden the indication for Totect to now include reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women.
This impacts women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control.
Totect was first approved in September 2007 for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
Shaun Chilton, group chief executive officer, Clinigen, said: 'This exceptional accomplishment by our Global Regulatory and Medical Affairs teams makes Totect the first and only FDA approved dexrazoxane product with a dual indication for the treatment of extravasation resulting from intravenous anthracycline chemotherapy as well as cardiomyopathy associated with doxorubicin in appropriately indicated women with metastatic breast cancer. As we continue to expand our global footprint, our commitment and primary focus remains on fulfilling our corporate mission to deliver the Right Medicine to the Right Patient at the Right Time.'
At 9:19am: (LON:CLIG) City of London Investment Group PLC share price was -8p at 405.5p
Story provided by StockMarketWire.com
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