Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

ABSTRACT

In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, 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 criti-cal events in the history of new drug development and reaserch are emphasized.