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Rockwell Medical Inc Triferic (SFP) NDA[removed]Errata to Applicant Briefing Document ODAC Meeting Date November 6, 2014
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Company

Public Release 1 Rockwell Medical Inc / Any SAE Relatednessa Related AE / Public Release 8 Rockwell Medical Inc / Public Release 5 Rockwell Medical Inc / ALL Safety Populations Any AE / Public Release 4 Rockwell Medical Inc / Public Release 9 Rockwell Medical Inc / Public Release 3 Rockwell Medical Inc / Public Release 2 Rockwell Medical Inc / Public Release 6 Rockwell Medical Inc / ROCKWELL MEDICAL INC. / the AEs / /

MedicalCondition

Muscle spasms Asthenia Hyperkalemia Back pain Anemia Hypertension NEW / graft thrombosis Infections / systemic/serious infections / HD vascular access thrombotic events Arteriovenous fistula / graft thrombosis HD / hypersensitivity / Back pain / vascular access thrombotic events Arteriovenous fistula / intradialytic hypotension / /

MedicalTreatment

Hemodialysis / catheter / /

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