In Brief: J&J's Rivizor
Executive Summary
J&J's Rivizor: Oncologic Drugs Advisory Committee review of Janssen's vorozole (NDA 20-817) scheduled for Sept. 18 is cancelled at the company's request. The committee will convene beginning at 1 p.m. Sept. 18 to review Sanofi/QLT's Photofrin for use in non-small cell lung cancer. Rivizor meeting is one of several committee reviews dropped at the request of sponsors this year, including OTC switches for Glaxo Wellcome's Beconase and Schering-Plough's Vancenase beclomethasone products, and Bristol-Myers Squibb's Droxia (hydroxyurea) for sickle-cell anemia pain. FDA's faster pace in getting drugs to the final stages of review may be creating a new set of problems for sponsors..
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