FDA's Novantrone concerns

WASHINGTON -- The FDA today began implementation of its court-mandated disclosure of advisory panel documents, disclosing the issues it is weighing in its review of Immunex Corp.'s application for approval of Novantrone mitoxantrone to slow progression of neurologic disability and reduce the relapse rate in patients with progressive multiple sclerosis.

The hundreds of pages of review materials posted on the agency's web site, included a Jan. 2 "Director's Memorandum" to members of the Peripheral and Central Nervous Systems Drugs Advisory panel on Novantrone, which is to meet Friday to review Novantrone. ...