Original New Drug Application Approvals by US FDA (1-15 March 2025)

04 Apr 2025
Original New Drug Application Approvals by US FDA (1-15 March 2025)
New drug applications approved by US FDA as of 1-15 March 2025 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.

OMLYCLO
  • Active Ingredient(s): Omalizumab-igec
  • Strength: 75MG/0.5ML; 150MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion Inc
  • Approval Date: 7 March 2025
  • Submission Classification: NA
  • Indication(s): Indicated for:
    • Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids
    • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment
    • IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance
    • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment
    Limitations of Use
    • Not indicated for acute bronchospasm or status asthmaticus.
    • Not indicated for the emergency treatment of allergic reactions, including anaphylaxis
    • Not indicated for other forms of urticaria.
  • Approved Label:  7 March 2025 (PDF)
EPINEPHRINE
  • Active Ingredient(s): Epinephrine
  • Strength: 30MG/30ML(1MG/ML)
  • Dosage Form(s) / Route(s): Solution;intramuscular, Intravenous, Subcutaneous
  • Company: Fresenius Kabi Usa
  • Approval Date: 13 March 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
    • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
  • Approved Label:  13 March 2025 (PDF)
ARBLI
  • Active Ingredient(s): Losartan Potassium
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Scienture Llc
  • Approval Date: 13 March 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
    • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients.
    • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
  • Approved Label:  13 March 2025 (PDF)
TYENNE
  • Active Ingredient(s): Tocilizumab-aazg
  • Strength: 80MG/4ML(20MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Fresenius Kabi Usa
  • Approval Date: 14 March 2025
  • 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:  14 March 2025 (PDF)