FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research

FOOD AND DRUG ADMINISTRATION
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

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.

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