Tag Archives: Promacta

November, 2018

19 November
FDA Approves Novartis’ Promacta for first-line SAA and Grants Breakthrough Therapy Designation for Additional New Indication

Basel, November 16, 2018 – Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label for Promacta® (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST). Promacta, which is marketed as Revolade® in most countries …
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31 May
FDA Expedites Review of Novartis’ Promacta for First-Line Severe Aplastic Anemia

Basel, May 30, 2018 – Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta®(eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA). Promacta, which is marketed as …
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5 January
FDA Grants Breakthrough Therapy Designation to Novartis’ Promacta for Treatment of Severe Aplastic Anemia

Basel, January 4, 2018 – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Promacta®(eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia (SAA) as a first-line therapy. Promacta, which is marketed as Revolade® in most …
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12 June
Novartis’ Promacta Approved for Children with a Rare Blood Disorder

US health regulators expanded approval of Novartis’ Promacta to treat children with a rare blood disorder. Novartis said that the US Food and Drug Administration (FDA) approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to …
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