Cardiovascular and Renal Drugs Advisory Committee

Meeting

December 9, 2003

Agenda

 

Hilton, The Ballrooms, Gaithersburg, MD

 

 

8:00 - 8:10 a.m. Call to Order and Introductions Jeffery Borer, M.D.

Chair, Cardiovascular and Renal Drugs

Advisory Committee

 

Conflict of Interest Statement Dornette Spell-LeSane, M.H.A., NP-C

Executive Secretary, FDA

 

8:30 - 8:45 a.m. Welcome and Introductory Comments Douglas Throckmorton, M.D.

Division of Cardiovascular and Renal Drugs

FDA

 

 


The committee will discuss new drug application NDA 21-526 CV Therapeutics

Proposed tradename Ranexa (ranolazine) 375 mg and 500 mg tablets

for treatment of chronic stable angina

 

 

8:45 a.m. Sponsor Presentation

 

CV Therapeutics

 

 

10:15 10:30 Break

 

10:30 10:45 Questions from the Committee

 

10:45 12:00 Committee Discussions

 

12:00 1:00 Lunch

 

1:00 1:30 Open Public Hearing

 

1:30 2:30 Committee Discussions

 

2:30 3:30 Committee Questions

 

3:30 3:45 Break

 

3:45 4:30 Questions/ Summary

 

4:30 p.m. Adjournment