Original New Drug Application Approvals by US FDA (16-31 March 2024)

04 Apr 2024
Original New Drug Application Approvals by US FDA (16-31 March 2024)
New drug applications approved by US FDA as of 16-31 March 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.

TRYVIO
  • Active Ingredient(s): Aprocitentan
  • Strength: 12.5MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Idorsia Pharma Ltd
  • Approval Date: 19 March 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Approved Label:  19 March 2024 (PDF)
DUVYZAT
  • Active Ingredient(s): Givinostat
  • Strength: 8.86MG/ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Italfarmaco Sa
  • Approval Date: 21 March 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
  • Approved Label:  21 March 2024 (PDF)
OPSYNVI
  • Active Ingredient(s): Macitentan And Tadalafil
  • Strength: 10MG;20MG, 10MG;40MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Actelion
  • Approval Date: 22 March 2024
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II-III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.
  • Approved Label:  22 March 2024 (PDF)
WINREVAIR
  • Active Ingredient(s): Sotatercept-csrk
  • Strength: 45MG, 60MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Merck Sharp Dohme
  • Approval Date: 26 March 2024
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.
  • Approved Label:  26 March 2024 (PDF)
VAFSEO
  • Active Ingredient(s): Vadadustat
  • Strength: 150MG, 300MG, 450MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Akebia Therapeutics Inc
  • Approval Date: 27 March 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated:
    • for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
    Limitations of Use:
    • Not been shown to improve quality of life, fatigue, or patient well-being.
    Not indicated for use:
    • As a substitute for transfusion in patients requiring immediate correction of anemia.
    • In patients with anemia due to CKD not on dialysis.
  • Approved Label:  27 March 2024 (PDF)
RISVAN
  • Active Ingredient(s): Risperidone
  • Strength: 75MG, 100MG
  • Dosage Form(s) / Route(s): Injectable; Suspension
  • Company: Laboratorios Farmaceuticos Rovi Sa
  • Approval Date: 29 March 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of schizophrenia in adults.
  • Approved Label:  29 March 2024 (PDF)