Introduction and analysis to the U.S. FDA's new drug approvals in 2010
- Author:
Zhong-Ming TANG
1
Author Information
1. Institute of Radiation Medicine
- Publication Type:Journal Article
- Keywords:
Adverse reactions;
Chemical structure;
Indications;
Mechanism;
New biological product;
New drug approval;
New molecular entity;
The U.S. FDA
- From:
Journal of International Pharmaceutical Research
2011;38(1):71-85
- CountryChina
- Language:Chinese
-
Abstract:
In 2010, the U.S. FDA totally approved 24 new drugs, including 11 new molecular entities, 10 new biological products and 3 new vaccines. According to the prescribing information of drug specifications, this article outlines the properties, chemical name and structure, action of mechanism, manufacturer, indication, dosage and usage, contraindications, adverse reactions, boxed warning and other relevant informations of them. In addition, the "first events" in the history of new drug research and development in 2010 are also summarized, and the overview of the new drugs approval by FDA from the years of 2008 to 2010 is also analyzed.
