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

03 Sep 2026
Original New Drug Application Approvals by US FDA (1-15 August 2026)
New drug applications approved by US FDA as of 1-15 August 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.

ORZEYFUL
  • Active Ingredient(s): Oveporexton
  • Strength: 0.05 MG/1 MG/2 MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Takeda Pharms USA
  • Approval Date: 5 August 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adult patients.
  • Approved Label:  5 August 2026 (PDF)
TAUKLARIFY
  • Active Ingredient(s): Florquinitau F-18
  • Strength: 1-40mCi/ML
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Cerveau Technologies INC A Lantheus Co
  • Approval Date: 13 August 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology.
    Limitations of Use
    The safety and effectiveness of TAUKLARIFY have not been established for the evaluation of non-Alzheimer’s disease tauopathies.
  • Approved Label:  13 August 2026 (PDF)
ZENBEXUS
  • Active Ingredient(s): Iberdomide Hydrochloride
  • Strength: EQ 0.75MG BASE; EQ 1MG BASE
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Bristol Myers Squibb
  • Approval Date: 13 August 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
    This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  13 August 2026 (PDF)