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-   -   Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) For T (https://her2support.org/vbulletin/showthread.php?t=41042)

News 09-11-2009 05:10 AM

Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) For T
 
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.

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