FDA Approvals, In Brief: Novartis’ Meningitis Vaccine Bexsero Gets Early Nod
This article was originally published in The Pink Sheet Daily
Also, Rockwell’s iron deficiency treatment Triferic gains agency approval, but without a dose-sparing claim related to erythropoiesis-stimulating agents; Symplmed’s perindopril/amlodipine fixed-dose combination approved for hypertension.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Rockwell Medical has filed an NDA for the iron replacement therapy, which will be positioned as an alternative to I.V. iron during dialysis and could limit the need for erythropoietin-stimulating agents.
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.