Chapter 5 98 Generic name Sponsor Pivotal9 Efficacy10 FDA11 EMA sodium phenylacetate and sodium benzoate Medicis Pharmaceutical FDA FDA 2005 N stavudine Bristol-Myers Squibb no EMA 1994 1996 stiripentol Biocodex no FDA/EMA 2018 2007 trabectedin Pharma Mar no EMA 2015 2007 trientine tetrahydrochloride GMP-Orphan SA no EMA N 2017 uridine triacetate Wellstat Therapeutics FDA FDA 2015 N velmanase α Chiesi Farmaceutici EMA EMA N 2018 vestronidase α Ultragenyx FDA FDA 2017 2018 ziconotide RIEMSER Pharma no EMA 2004 2005
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