Protalix Of Israel To Refile For U.S. Approval Of Gaucher's Drug
This article was originally published in PharmAsia News
Executive Summary
Israel's Protalix Biotherapeutics plans to refile a new drug application with U.S. FDA, which rejected its first drug, Uplyso (taliglucerase) for treating Gaucher's disease
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Israel's Protalix Biotherapeutics plans to refile a new drug application with U.S. FDA, which rejected its first drug, Uplyso (taliglucerase) for treating Gaucher's disease. The agency rejected the initial Protalix application in February, but sources say the FDA has since hinted it looks forward to the reapplication for the drug considered similar to Genzyme Genetic's Cerezyme (imiglucerase). Protalix focuses on a technology that allows it to compete with protein-based drugs without infringing on patents. Protalix would not comment on the reports. (Click here for more) "Protalix to Re-File With FDA For Gaucher's Drug" - Globes (Israel) (7/21/11) |