PERIPHERAL & CENTRAL NERVOUS SYSTEM ADVISORY COMMITTEE
JANUARY 28, 2000
Novantrone (mitoxantrone) indicated in Multiple Sclerosis
NDA 21-120
Briefing Information
FOOD AND DRUG ADMINISTRATION
IMMUNEX
Disclaimer
The statements contained in this document 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.
1.0 Background on Multiple Sclerosis
3.0 Clinical Development Program in Multiple Sclerosis
4.0 Efficacy of Mitoxantrone in Multiple Sclerosis
6.0 Benefit and Risk Assessment
7.0 Post-Marketing Commitments