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SOBI 'temporarily' withdraws Orfadin oral suspension NDA on FDA info request

This article was originally published in Scrip

Executive Summary

Swedish Orphan Biovitrum, better known as SOBI, on 27 December disclosed it was withdrawing its new drug application (NDA) for Orfadin (nitisinone) oral suspension in the US, owing the decision to the FDA's request for more information about the usability of the product by the intended population the oral syringe that will be included in the packaging.



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