Análisis de los nuevos principios activos comercializados en España (1992-2002)

Abstract

Objectives. To describe the active principles (AP) marketed in Spain from 1992 to 2002, to determine their characteristics, and to find whether they supposed genuine therapeutic advances (TA). Design. Transversal, descriptive study. Main measurements. The degree of TA in the AP analysed was studied with the classification used by the FDA (A*: exceptional therapeutic novelty; A: important therapeutic novelty; B: modest therapeutic improvement; C: null or very little therapeutic improvement, corresponding to "me-too" drugs; and D: not classified), the context of use and the price. Results. 369 new AP were marketed. 3.5% were in group A*, 11.9% in A, 30.1% in B, 49.3% in C, and 5.1% in D. 42.3% corresponded to AP used in hospitals for therapy or diagnosis. Significant differences were found (P