Original New Drug Application Approvals by US FDA (16-31 January 2026)

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Original New Drug Application Approvals by US FDA (16-31 January 2026)
New drug applications approved by US FDA as of 16-31 January 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

AVTOZMA
  • Active Ingredient(s): Tocilizumab-anoh
  • Strength: 80MG/4ML(20MG/ML); 200MG/10ML(20MG/ML); 400MG/20ML(20MG/ML)
  • Dosage Form(s) / Route(s): Injectable;iv (Infusion)
  • Company: Celltrion Inc
  • Approval Date: 21 January 2026
  • Submission Classification: NA
  • Indication(s): Indicated for treatment of:
    • Rheumatoid Arthritis (RA)
    • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
    Giant Cell Arteritis (GCA)
    • Adult patients with giant cell arteritis.
    Polyarticular Juvenile Idiopathic Arthritis (PJIA)
    • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
    Systemic Juvenile Idiopathic Arthritis (SJIA)
    • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
    Cytokine Release Syndrome (CRS)
    • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
    Coronavirus Disease 2019 (COVID-19)
    • Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
  • Approved Label:  21 January 2026 (PDF)
AVTOZMA
  • Active Ingredient(s): Tocilizumab-anoh
  • Strength: 162MG/20ML(20MG/ML)
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Celltrion Inc
  • Approval Date: 21 January 2026
  • Submission Classification: NA
  • Indication(s): Indicated for treatment of:
    • Rheumatoid Arthritis (RA)
    • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
    Giant Cell Arteritis (GCA)
    • Adult patients with giant cell arteritis.
    Polyarticular Juvenile Idiopathic Arthritis (PJIA)
    • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
    Systemic Juvenile Idiopathic Arthritis (SJIA)
    • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
    Cytokine Release Syndrome (CRS)
    • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
    Coronavirus Disease 2019 (COVID-19)
    • Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
  • Approved Label:  21 January 2026 (PDF)
YUVEZZI
  • Active Ingredient(s): Carbachol And Brimondine Tartrate
  • Strength: 2.75%/0.1%
  • Dosage Form(s) / Route(s): Solution;topical
  • Company: Visus Therapeutics Inc.
  • Approval Date: 28 January 2026
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of presbyopia in adults.
  • Approved Label:  28 January 2026 (PDF)