Original New Drug Application Approvals by US FDA (16-31 December 2022)

31 Dec 2022
Original New Drug Application Approvals by US FDA (16-31 December 2022)
New drug applications approved by US FDA as of 16 - 31 December 2022 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.

OLPRUVA
  • Active Ingredient(s): Sodium Phenylbutyrate
  • Strength: 2G; 3G; 4G; 5G; 6G; 6.67G
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Acer Therapeutics Inc
  • Approval Date: 22 December 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

    Limitations of Use: OLPRUVA is not indicated for the treatment of acute hyperammonemia.
  • Approved Label:  22 December (PDF)
SUNLENCA
  • Active Ingredient(s): Lenacapavir
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Gilead Sciences
  • Approval Date: 22 December 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
  • Approved Label:  22 December (PDF)
SUNLENCA
  • Active Ingredient(s): Lenacapavir
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Gilead Sciences
  • Approval Date: 22 December 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
  • Approved Label:  22 December (PDF)
LUNSUMIO
  • Active Ingredient(s): Mosunetuzumab-axgb
  • Strength: 1MG/ML; 30MG/30ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Genentech Inc
  • Approval Date: 22 December 2022
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

    This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  22 December (PDF)
XENOVIEW
  • Active Ingredient(s): Xenon Xe 129 Hyperpolarized
  • Strength: 1000ML
  • Dosage Form(s) / Route(s): Inhalant;oral
  • Company: Polarean Inc
  • Approval Date: 23 December 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

    Limitations of Use:
    XENOVIEW has not been evaluated for use with lung perfusion imaging.
  • Approved Label:  23 December (PDF)
BRIUMVI
  • Active Ingredient(s): Ublituximab
  • Strength: 25 MG/ML
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Tg Therapeutics, Inc
  • Approval Date: 28 December 2022
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Approved Label:  28 December (PDF)