Food and Drug Administration

Oncologic Drugs Advisory Committee

March 13, 2003

Briefing Information

Mylotarg® (gemtuzumab ozogamicin for Injection), Wyeth-Ayerst Lab. (HTM) (PDF) (Word)

Letter From Gordon Schooley, PhD, Regarding NDA 21-041 DepoCyt® Phase IV Commitments, SkyePharma, Inc. (HTM) (PDF) (Word)

Celecoxib (Celebrex®) Therapy of Familial Adenomatouse Polyposis, Pharmacia Corp. (HTM) (PDF) (Word)

Background Information Regarding Accelerated Approval Clinical Phase IV Commentments NDA 21-029 TEMODAR® (temozolomide), Schering-Plough Corp. (HTM) (PDF) (Word)