DATE AND TIME: July 24, 8 a.m.
LOCATION: Advisors and Consultants Staff Conference Room, 5630 Fishers Lane, Rm. 1066, Rockville, MD.
CONTACT: Johanna Clifford, Center for Drug Evaluation and Research, 301-827-6761.
The FDA's Oncologic Drugs Advisory Committee will discuss new drug applications for NDA 022-042, EVISTA (raloxifene hydrochloride) Tablets, Eli Lilly and Co., proposed indications for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of breast cancer; and NDA 021-801, proposed trade name ORPLANTA (satraplatin capsules), GPC Biotech Inc., proposed indication for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) that has failed prior chemotherapy. More Information