Original New Drug Application Approvals by US FDA (16-30 April 2026)

11 May 2026
Original New Drug Application Approvals by US FDA (16-30 April 2026)
New drug applications approved by US FDA as of 16-30 April 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.

IDVYNSO
  • Active Ingredient(s): Doravirine And Islatravir
  • Strength: 100MG/0.25MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Merck Sharp And Dohme LLC
  • Approval Date: 20 April 2026
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
  • Approved Label:  20 April 2026 (PDF)
SAPHNELO
  • Active Ingredient(s): Anifrolimab-fnia
  • Strength: 300MG/2ML (150MG/ML)
  • Dosage Form(s) / Route(s): Vial; Single-use
  • Company: Astrazeneca Ab
  • Approval Date: 24 April 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
    Limitations of Use
    The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
  • Approved Label:  24 April 2026 (PDF)
SAPHNELO
  • Active Ingredient(s): Anifrolimab-fnia
  • Strength: 120MG/0.8ML
  • Dosage Form(s) / Route(s): Injection
  • Company: Astrazeneca Ab
  • Approval Date: 24 April 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
    Limitations of Use
    The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
  • Approved Label:  24 April 2026 (PDF)
LANGLARA
  • Active Ingredient(s): Insulin Glargine-aldy
  • Strength: 100UNITS/ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Sunshine Lake Pharma Co LTD
  • Approval Date: 29 April 2026
  • Submission Classification: NA
  • Indication(s): Indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
    Limitations of Use
    Not recommended for the treatment of diabetic ketoacidosis.
  • Approved Label:  29 April 2026 (PDF)