Cancer

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Published in Medical Letter on the CDC and FDA, September 27th, 2009

Centocor Ortho Biotech Products, L.P. announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

Centocor Ortho Biotech is evaluating the FDA's letter and will respond to the agency as quickly as possible.

The sNDA for DOXIL was submitted to the FDA in September 2008. DOXIL currently is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior...

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Source: Medical Letter on the CDC and FDA (2009-09-27)

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