Journal of International Pharmaceutical Research 2014;(4):493-502

doi:10.13220/j.cnki.jipr2014.04.020

Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year

Zhongming TANG

Keywords

new drug approval; the U.S. FDA; new molecular entity; new biological products; chemical structure; mech-anism; indications; adverse reactions

Country

China

Language

Chinese

Abstract

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.