Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year
10.13220/j.cnki.jipr2014.04.020
- VernacularTitle:2014年上半年美国FDA批准药物简介
- Author:
Zhongming TANG
- Publication Type:Journal Article
- Keywords:
new drug approval;
the U.S. FDA;
new molecular entity;
new biological products;
chemical structure;
mech-anism;
indications;
adverse reactions
- From:
Journal of International Pharmaceutical Research
2014;(4):493-502
- CountryChina
- 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.
