Original New Drug Application Approvals by US FDA (1-15 July 2024)

17 Jul 2024
Original New Drug Application Approvals by US FDA (1-15 July 2024)
New drug applications approved by US FDA as of 1-15 July 2024 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.

KISUNLA
  • Active Ingredient(s): Donanemab-azbt
  • Strength: 350MG/20ML(17.5MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Eli Lilly Co
  • Approval Date: 2 July 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of Alzheimer’s disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
  • Approved Label:  2 July 2024 (PDF)
VASOPRESSIN IN SODIUM CHLORIDE INJECTION
  • Active Ingredient(s): Vasopressin
  • Strength: 20 UNITS/100ML (0.2 UNITS/ML); 40 UNITS/100ML (0.4 UNITS/ML); 50 UNITS/50 ML (1 UNIT/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Long Grove Pharms
  • Approval Date: 11 July 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
  • Approved Label:  11 July 2024 (PDF)