FDA grants approval to broaden indication for Totect®

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 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.

Clinigen Group’s 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.”

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