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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...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Korean Society for Clinical Pharmacology and Therapeutics
2018
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| 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 |