Center for Drug Evaluation and Research

Dermatologic and Ophthalmic Drugs Advisory Committee

November 16, 2000

NDA 50-777, (tacrolimus) ointment, Fujisawa Healthcare, for short and long term treatment of the signs and symptoms of atopic dermatitis in adults and pediatric patients 2 years of age or older


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.

Fujisawa Healthcare, Inc.

Introduction, Jerry D Johnson, PhD   ppt   html

Pharmacology of Tacrolimus Ointment, William Fitzsimmons, PharmD   ppt   html

Efficacy and Safety of Tacrolimus Ointment, Ira D Lawrence, MD   ppt   html

FDA Presentation

Nonclinical Pharmacology/Toxicology Data for Protopic, Barbara Hill PhD   ppt   html

Systemic Exposure of Topical Tacrolimus, Veneeta Tandon PhD   ppt   html

Clinical Review of Protopic Ointment, Potential Risk and Efficacy, Martin Okun MD PhD & Lisa Mathis MD   ppt   html

Letter to Jonathan K Wilkin MD & Dr Kalyani Bahtt, FDA, from Peter M Elias MD, Veterans Administration, Dated October 30, 2000   pdf