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

New drug applications approved by US FDA as of 1-15 October 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.

TRABECTEDIN

• Active Ingredient(s): Trabectedin
• Strength: 1MG/VIAL
• Dosage Form(s) / Route(s): Powder;intravenous
• Company: Ever
• Approval Date: 1 October 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
• Approved Label:  1 October 2026 (PDF)

WELTRUZA

• Active Ingredient(s): Olanzapine
• Strength: 318MG; 425MG; 531MG
• Dosage Form(s) / Route(s): Powder;subcutaneous
• Company: Teva
• Approval Date: 8 October 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of schizophrenia in adults.
• Approved Label:  8 October 2026 (PDF)

BREZTRI AEROSPHERE

• Active Ingredient(s): Budesonide; Formoterol Fumarate; Glycopyrrolate
• Strength: 0.16MG/INH;0.0048MG/INH;0.009MG/INH, 0.16MG/INH;0.0048MG/INH;0.018MG/INH
• Dosage Form(s) / Route(s): Aerosol, Metered;inhalation
• Company: Astrazeneca Ab
• Approval Date: 8 October 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for:
  • the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
  • the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.
• Approved Label:  8 October 2026 (PDF)

ISOVUE READI

• Active Ingredient(s): Iopamidol
• Strength: 9MG IODINE/ML; 250MG; 300MG; 370MG
• Dosage Form(s) / Route(s): Solution; Oral
• Company: Bracco
• Approval Date: 9 October 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for:
  Intra-arterial Procedures
  
  • Cerebral arteriography, peripheral arteriography, and selective arteriography and aortography, coronary arteriography, and cardiac ventriculography in adults
  • Angiocardiography in pediatric patients
  Intravenous Procedures
  
  • Excretory urography and computed tomography (CT) of head and body in adults and pediatric patients
  • Peripheral venography in adults
  ISOVUE and ISOVUE READI are indicated for:
  Oral Procedures
  
  • CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients
• Approved Label:  9 October 2026 (PDF)

HOVILPRI

• Active Ingredient(s): Pritelivir
• Strength: EQ100MG BASE
• Dosage Form(s) / Route(s): Tablet; Oral
• Company: Aicuris Anti-Infect
• Approval Date: 9 October 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated in immunocompromised adults for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir.
• Approved Label:  9 October 2026 (PDF)

EVOXAC

• Active Ingredient(s): Cevimeline Hydrochloride
• Strength: 30MG/5ML
• Dosage Form(s) / Route(s): Solution;oral
• Company: Cosette
• Approval Date: 15 October 2026
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.
• Approved Label:  15 October 2026 (PDF)