Original New Drug Application Approvals by US FDA (15-30 September 2023)

10 Oct 2023
Original New Drug Application Approvals by US FDA (15-30 September 2023)
New drug applications approved by US FDA as of 15-30 September 2023 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.

EXXUA
  • Active Ingredient(s): Gepirone
  • Strength: 18.2MG, 36.3MG, 54.5MG, 72.6MG
  • Dosage Form(s) / Route(s): Tablet, Extended Release;oral
  • Company: Fabre-kramer Pharmaceuticals, Inc.
  • Approval Date: 22 September 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of major depressive disorder (MDD) in adults.
  • Approved Label:  22 September (PDF)
LIKMEZ
  • Active Ingredient(s): Metronidazole
  • Strength: 500MG/5ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Saptalis Pharmaceuticals, Llc
  • Approval Date: 22 September 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • Trichomoniasis in adults
    • Amebiasis in adults and pediatric patients
    • Anaerobic Bacterial Infections in adults

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  22 September 2023 (PDF)
RYZUMVI
  • Active Ingredient(s): Phentolamine
  • Strength: 0.75%
  • Dosage Form(s) / Route(s): Solution;ophthalmic
  • Company: Ocuphire Pharma Inc
  • Approval Date: 25 September 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.
  • Approved Label:  25 September 2023 (PDF)
BOSULIF
  • Active Ingredient(s): Bosutinib
  • Strength: 100MG, 400MG, 500MG, 50MG, 100MG
  • Dosage Form(s) / Route(s): Tablet;oral, Capsule;oral
  • Company: Ocuphire Pharma Inc
  • Approval Date: 26 September 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of
    • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.
    • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
  • Approved Label:  26 September 2023 (PDF)
ENTYVIO
  • Active Ingredient(s): Vedolizumab
  • Strength: 300MG, 108MG/0.68ML
  • Dosage Form(s) / Route(s): Injectable;intravenous, Injectable;injection
  • Company: Takeda Pharms Usa
  • Approval Date: 27 September 2023
  • Submission Classification: NA
  • Indication(s): Indicated in adults for the treatment of:
    • moderately to severely active ulcerative colitis (UC).
    • moderately to severely active Crohn’s disease (CD)
  • Approved Label:  27 September 2023 (PDF)
OPFOLDA
  • Active Ingredient(s): Miglustat
  • Strength: 65MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Amicus Therap US
  • Approval Date: 28 September 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated, in combination with Pombiliti, a hydrolytic lysosomal glycogen-specific enzyme, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
  • Approved Label:  28 September 2023 (PDF)
POMBILITI
  • Active Ingredient(s): Cipaglucosidase Alfa-atga
  • Strength: 105MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Amicus Therap US
  • Approval Date: 28 September 2023
  • Submission Classification: N/A
  • Indication(s): Indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
  • Approved Label:  28 September 2023 (PDF)
TECHNEGAS
  • Active Ingredient(s): Technetium Tc 99m Carbon
  • Strength: 1.25G
  • Dosage Form(s) / Route(s): Liquid; Inhalation
  • Company: Cyclomedica Australia Pty Ltd
  • Approval Date: 29 September 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for use in adults and pediatric patients aged 6 years and older for:
    • visualization of pulmonary ventilation
    • evaluation of pulmonary embolism when paired with perfusion imaging
  • Approved Label:  29 September 2023 (PDF)
RIVFLOZA
  • Active Ingredient(s): Nedosiran
  • Strength: 80MG(0.5ML), 128MG(0.8ML), 160MG(1ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Novo Nordisk Inc
  • Approval Date: 29 September 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2.
  • Approved Label:  29 September 2023 (PDF)
MICAFUNGIN
  • Active Ingredient(s): Micafungin Sodium
  • Strength: 50MG/50ML, 100MG/100ML, 150MG/150ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Baxter Hlthcare Corp
  • Approval Date: 29 September 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adult and pediatric patients for (1):
    • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved.
    • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved.
    • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved.
    • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) for whom appropriate dosing with this formulation can be achieved.
  • Approved Label:  29 September 2023 (PDF)
VASOPRESSIN IN SODIUM CHLORIDE INJECTION
  • Active Ingredient(s): Vasopressin In Sodium Chloride Injection
  • Strength: 0.2UNITS/ML / VIAL, 0.4UNITS/ML / VIAL
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Baxter Hlthcare Corp
  • Approval Date: 29 September 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
  • Approved Label:  29 September 2023 (PDF)
TOFIDENCE
  • Active Ingredient(s): Tocilizumab-bavi
  • Strength: 80MG/4ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Biogen MA
  • Approval Date: 29 September 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for treatment of:
    Rheumatoid Arthritis (RA)
    • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

    Polyarticular Juvenile Idiopathic Arthritis (PJIA)
    • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

    Systemic Juvenile Idiopathic Arthritis (SJIA)
    • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
  • Approved Label:  29 September 2023 (PDF)

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