Anti-Infective Drugs Advisory Committee

March 24, 2000

Briefing Information

Zyox (linezolid) NDA 21-130, NDA 21-131, NDA 21-132

FDA Briefing Package doc pdf

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.

 Pharmacia & Upjohn Company

Brochure

Appendix A: Preclinical Summary

Part I

Part II

Appendix B: Study Synopses

Study 31

Study 33

Study 39

Study 39A

Study 48A

Study 51

Study 54A

Study 55