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

26 Apr 2024
Original New Drug Application Approvals by US FDA (1-15 April 2024)
New drug applications approved by US FDA as of 1-15 April 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.

ZEVTERA
  • Active Ingredient(s): Ceftobiprole Medocaril Sodium
  • Strength: 667MG/VIAL
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Basilea Pharm Allsch
  • Approval Date: 3 April 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of:
    • Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis
    • Adult patients with acute bacterial skin and skin structure infections (ABSSSI), and
    • Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  3 April 2024 (PDF)
XROMI
  • Active Ingredient(s): Hydroxyurea
  • Strength: 100MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Nova Labs Ltd
  • Approval Date: 4 April 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.
  • Approved Label:  4 April 2024 (PDF)
RETEVMO
  • Active Ingredient(s): Selpercatinib
  • Strength: 40MG, 80MG, 120MG, 160MG
  • Dosage Form(s) / Route(s): Capsule;oral / Tablet;oral
  • Company: Loxo Oncol Eli Lilly
  • Approval Date: 10 April 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for for the treatment of:
    • Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
    • Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  10 April 2024 (PDF)
ENTRESTO
  • Active Ingredient(s): Sacubitril;valsartan
  • Strength: 97MG;103MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis
  • Approval Date: 12 April 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
    • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
  • Approved Label:  12 April 2024 (PDF)
ENTRESTO SPRINKLE
  • Active Ingredient(s): Sacubitril;valsartan
  • Strength: 6MG;6MG, 15MG;16MG,
  • Dosage Form(s) / Route(s): Capsule, Pellets;oral
  • Company: Novartis
  • Approval Date: 12 April 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
    • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
  • Approved Label:  12 April 2024 (PDF)