ONCOLOGIC DRUGS ADVISORY COMMITTEE
December 13, 2000
Briefing Information
NDA 20-726/S-006, FEMARA (letrozole) TABLETS
(First-Line Breast Cancer Indication)
Novartis Pharmaceuticals Corporation
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.
Food and Drug Administration
Clinical Pharmacology & Biopharmaceutics
NDA 21-240 HISTAMINE HYDROCHLORIDE INJECTION
Maxim Pharmaceuticals, Inc.
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.
Food and Drug Administration
Clinical Pharmacology & Biopharmaceutics