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Complete Response Letter for Centocor’s Doxil

J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer. Centocor is evaluating the letter and plans to respond to the agency as quickly as possible. The sNDA for Doxil was submitted in September 2008. Doxil is currently indicated for the treatment of ovarian cancer that has progressed or recurred after prior plati...

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