PERIPHERAL & CENTRAL NERVOUS SYSTEM ADVISORY COMMITTEE

JANUARY 28, 2000

Novantrone (mitoxantrone) indicated in Multiple Sclerosis

NDA 21-120

Briefing Information

FOOD AND DRUG ADMINISTRATION

Current Product Label

Division Director's Memo

Safety Review

Statistical Review

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.

Cover Letter

Table of Contents

Executive Summary

1.0 Background on Multiple Sclerosis

2.0 Mitoxantronoe

3.0 Clinical Development Program in Multiple Sclerosis

4.0 Efficacy of Mitoxantrone in Multiple Sclerosis 

5.0 Safety Results

6.0 Benefit and Risk Assessment

7.0 Post-Marketing Commitments

8.0 Proposed Use in Patients with MS

9.0 References

Appendices