Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in Japan:

Background:New fixed-dose combinationdrugs (FDCs) had been developed in limited numbers in Japan. Since regulatory requirements were relaxed in 2005, 73 new FDCs have been approved by PMDA since 2006. In this study, we investigate trends in new FDCs and their benefits through a questionnaire survey provided to patients and pharmacists.Methods:The new FDCs were analyzed by therapeutic categories, first approval country and drug lag (DL). Questionnaire surveys were conducted on hypertension, bronchial asthma, and glaucoma in approximately 300 patients and 700 pharmacists in 66 hospitals to investigate the benefits of new FDCs.Results:The highest number of FDCs approved by the therapeutic category was 15 cardiovascular agents. The DL (median) was less than 1 year in several therapeutic categories including cardiovascular agents. The survey results showed that patient compliance improved in 30.8% of the bronchial asthma. Regarding the time and effort required to prescribe these drugs, 32.5% of pharmacists re...