Food and Drug Administration
Oncologic Drugs Advisory Committee
December 6, 2001
NDA 20-637/S016, GliadelŪ Wafer (carmustine), Guilford Pharmaceuticals Inc. - indicated for use as a treatment to significantly prolong survival and maintain overall function (as measured by preservation of Karnovsky Perfomance Status) and neurological function in patients with malignant glioma undergoing primary and/or recurrent surgical resection
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Guilford Pharmaceuticals [pdf version]
Food and Drug Administration Information
Clinical Review [pdf version] [Word version]