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Oncologic Drugs Advisory Committee Meeting Set By FDA

Medical Industry E-Mail News Service™ -- July 07 2009 -- The US Food & Drug Administration (FDA) has announced that its Oncologic Drugs Advisory Committee will meet on July 15 2009, in Gaithersburg MD, to discuss (1) new drug application (NDA) 022-447, proposed trade name Yondelis (trabectedin) powder, for concentrate for solution for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with Doxcil (doxorubicin HCl liposome injection), for treating patients with relapsed ovarian cancer; and (2) supplemental new drug application (sNDA) 050-718/S-039, Doxil (doxorubicin HCl liposome injection), for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with docetaxel for treating patients with locally advanced or metasatic breast cancer who have received prior anthracycline treatment. There is no charge to attend. When & Where July 15 2009; 8 am-5 pm Hilton Washington DC N/Gaithersburg Ballrooms 620 Perry Pkwy Gaithersburg MD FDA Center for Drug Evaluation & Research (HFD-21)


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