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)