Original New Drug Application Approvals by US FDA (1-15 July 2026)

27 Jul 2026
Original New Drug Application Approvals by US FDA (1-15 July 2026)
New drug applications approved by US FDA as of 1-15 July 2026 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.

TRUTAKNA
  • Active Ingredient(s): Atacicept-vymj
  • Strength: 150MG/ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Vera Therapeutics INC.
  • Approval Date: 7 July 2026
  • Submission Classification: NA
  • Indication(s): Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
    This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • Approved Label:  7 July 2026 (PDF)
SODIUM BICARBONATE
  • Active Ingredient(s): Sodium Bicarbonate
  • Strength: 150MEQ/1,000ML (0.15MEQ/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Amneal EU LTD
  • Approval Date: 9 July 2026
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis.
    • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion.
    • Limitation of Use
    Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.
  • Approved Label:  9 July 2026 (PDF)
SARCLISA ESCENA
  • Active Ingredient(s): Isatuximab-irfc
  • Strength: 1400MG/10ML (140MG/ML)
  • Dosage Form(s) / Route(s): Vial;single-dose
  • Company: Sanofi-aventis U.s. LLC
  • Approval Date: 9 July 2026
  • Submission Classification: NA
  • Indication(s): Indicated:
    • in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor.
    • in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
    • in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
  • Approved Label:  9 July 2026 (PDF)
ZYOGREEN
  • Active Ingredient(s): Indocyanine Green Injection
  • Strength: 25MG/10ML (2.5MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Provepharm Sas
  • Approval Date: 10 July 2026
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Fluorescence imaging of vessels (micro-and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro-and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients
    • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older
    • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer
    • Ophthalmic angiography in adults and pediatric patients
  • Approved Label:  10 July 2026 (PDF)