Original New Drug Application Approvals by US FDA (16 - 31 January 2022)

08 Feb 2022
Original New Drug Application Approvals by US FDA (16 - 31 January 2022)
New drug applications approved by US FDA as of 16-31 January 2022 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.

DAPZURA RT
  • Active Ingredient(s): Daptomycin
  • Strength: 500MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Baxter Hlthcare Corp
  • Approval Date: 25 January 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of:
    • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) and,
    • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis,
    • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age).
  • Approved Label: 25 January 2022 (PDF)
KIMMTRAK
  • Active Ingredient(s): Tebentafusp-tebn
  • Strength: 100MCG/0.5ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Immunocore Ltd
  • Approval Date: 25 January 2022
  • Submission Classification:Not available
  • Indication(s): Indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma 
  • Approved Label: 25 January 2022 (PDF)
VABYSMO
  • Active Ingredient(s): Faricimab-svoa
  • Strength: 120MG/ML
  • Dosage Form(s) / Route(s): Injectable; Intravitreal
  • Company: Genentech Inc
  • Approval Date: 28 January 2022
  • Submission Classification:Not available
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
    • Diabetic Macular Edema (DME)
  • Approved Label: 28 January 2022 (PDF)
CITALOPRAM
  • Active Ingredient(s): Citalopram Hydrobromide
  • Strength: 30MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Almatica
  • Approval Date: 31 January 2022
  • Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
  • Indication(s): Indicated for treatment of Major Depressive Disorder (MDD) in adults
  • Approved Label: 31 January 2022 (PDF)