Food and Drug Administration

Oncologic Drugs Advisory Committee

December 6, 2001

Briefing Information

Afternoon Session

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

Sponsor Information

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Guilford Pharmaceuticals   [pdf version]

Food and Drug Administration Information

Clinical Review  [pdf version]  [Word version]