Food and Drug Administration

Center for Drug Evaluation and Research (CDER)


Antiviral Drugs Advisory Committee


May 19, 2005



620 Perry Parkway

Gaithersburg, Maryland





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




Open Public Hearing


Discussion and Questions to the Committee



5:00                 Adjourn