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New Drug Approvals Archive - April 2018

April 2018

Tavalisse (fostamatinib) Tablets

Date of Approval: April 17, 2018
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).

Read more: Tavalisse (fostamatinib) FDA Approval History

Praxbind (idarucizumab)

Labeling Revision Approved: April 12, 2018
Treatment for: Reversal Agent for Pradaxa

Read more: Praxbind (idarucizumab) FDA Approval History

Crysvita (burosumab-twza) Injection

Date of Approval: April 17, 2018
Company: Ultragenyx Pharmaceutical Inc.
Treatment for: X-Linked Hypophosphatemia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH).

Read more: Crysvita (burosumab-twza) FDA Approval History

Akynzeo for Injection (fosnetupitant and palonosetron)

Date of Approval: April 19, 2018
Company: Helsinn
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Read more: Akynzeo for Injection (fosnetupitant and palonosetron) FDA Approval History

Jynarque (tolvaptan) Tablets

Date of Approval: April 23, 2018
Company: Otsuka Pharmaceutical Co., Ltd.
Treatment for: Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease

Jynarque (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Read more: Jynarque (tolvaptan) FDA Approval History

New Drug Approvals Archive