Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

 

Antiviral Drugs Advisory Committee

 

May 19, 2005

 

Hilton

620 Perry Parkway

Gaithersburg, Maryland

 

 

DRAFT AGENDA

 

The Antiviral Drugs Advisory Committee will discuss new drug application (NDA) 021-814, proposed tradename Aptivus (Tipranavir) 250 milligrams (mg) capsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for the treatment of patients with HIV.

 

8:00                 Call to Order and Opening Remarks                

 

                        Introduction of Committee                               

 

Conflict of Interest Statement                            Anuja Patel, M.P.H.

                                                                                                Executive Secretary, FDA

 

 

Overview of Issues

 

Sponsor Presentations

 

FDA Presentations

                       

Lunch

 

Open Public Hearing

 

Discussion and Questions to the Committee

 

 

5:00                 Adjourn