Original New Drug Application Approvals by US FDA (01-15 January 2023)

17 Jan 2023
Original New Drug Application Approvals by US FDA (01-15 January 2023)
New drug applications approved by US FDA as of 01-15 January 2023 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.

  • Active Ingredient(s): Cabazitaxel
  • Strength: 45MG/4.5ML (10MG/ML); 60MG/6ML (10MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Sandoz Inc
  • Approval Date: 05 January 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
  • Approved Label:  05 January (PDF)
  • Active Ingredient(s): Lecanemab-irmb
  • Strength: 500MG/5ML; 200MG/2ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Eisai Inc
  • Approval Date: 06 January 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
  • Approved Label:  06 January (PDF)
  • Active Ingredient(s): Albuterol And Budesonide
  • Strength: Albuterol 90mcg Budesonide 80mcg
  • Dosage Form(s) / Route(s): Aerosol, Metered;inhalation
  • Company: Bond Avillion 2 Development Lp
  • Approval Date: 10 January 2023
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older
  • Approved Label:  10 January (PDF)
  • Active Ingredient(s): Risperidone
  • Strength: 12.5MG; 25MG; 37.5MG; 50MG
  • Dosage Form(s) / Route(s): Injection, Suspension, Extended Release
  • Company: Shandong Luye Pharmaceutical Co Ltd
  • Approval Date: 13 January 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • for the treatment of schizophrenia in adults.
    • as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
  • Approved Label:  13 January 2023 (PDF)

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