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

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

ZYCUBO

• Active Ingredient(s): Copper Histidinate
• Strength: 2.9MG
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Sentynl Theraps Inc
• Approval Date: 12 January 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of Menkes disease in pediatric patients.
• Approved Label:  12 January 2026 (PDF)

FILKRI

• Active Ingredient(s): Filgrastim-laha
• Strength: 300MCG/0.5ML; 480MCG/0.8ML
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Accord Biopharma Inc.
• Approval Date: 15 January 2026
• Submission Classification: NA
• Indication(s): Indicated to:
• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
• Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
• Approved Label:  15 January 2026 (PDF)