Overviews and analysis of the U.S. FDA′s new approvals in first half year of 2015
10.13220/j.cnki.jipr.2015.04.019
- VernacularTitle:2015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;
mecha-nism;
indications;
adverse reactions
- From:
Journal of International Pharmaceutical Research
2015;(4):531-538
- CountryChina
- Language:Chinese
-
Abstract:
In the first half year of 2015, the U.S. Food and Drug Administration(FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes 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 and critical events in the history of new drug reaserch and development are emphasized.
