Cargando…

Data exclusivity through New Drug Reexamination in Korea: sibutramine hydrochloride (Reductil®) vs. sibutramine mesylate (Slimmer®) as an example

The ‘equivalent-or-more-but-not-the-same-data’ provision in the Regulation on the Safety and Efficacy Evaluation of New Drug in Korea has served as the de facto data exclusivity term for any drug identical to a product subject to new drug reexamination. The legal debate that occurred between Abbott...

Descripción completa

Detalles Bibliográficos
Autor principal: Lee, Howard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society for Clinical Pharmacology and Therapeutics 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989260/
https://www.ncbi.nlm.nih.gov/pubmed/32055548
http://dx.doi.org/10.12793/tcp.2018.26.2.49