Original New Drug Application Approvals by US FDA (16-30 June 2024)

15 Jul 2024
Original New Drug Application Approvals by US FDA (16-30 June 2024)
New drug applications approved by US FDA as of 16-30 June 2024 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.

VIGAFYDE
  • Active Ingredient(s): Vigabatrin
  • Strength: 100MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Pyros Pharms
  • Approval Date: 17 June 2024
  • Submission Classification: NA
  • Indication(s): Indicated for treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
  • Approved Label:  17 June 2024 (PDF)
SOFDRA
  • Active Ingredient(s): Sofpironium Bromide
  • Strength: EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
  • Dosage Form(s) / Route(s): Gel, Metered;topical
  • Company: Botanix Sb
  • Approval Date: 18 June 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
  • Approved Label:  18 June 2024 (PDF)
PIASKY
  • Active Ingredient(s): Crovalimab-akkz
  • Strength: 340MG/2ML(170MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Genentech Inc
  • Approval Date: 20 June 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
  • Approved Label:  20 June 2024 (PDF)
TEPYLUTE
  • Active Ingredient(s): Thiotepa
  • Strength: 15MG/1.5ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Shorla
  • Approval Date: 25 June 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for for the treatment of adenocarcinoma of the breast or ovary.
  • Approved Label:  25 June 2024 (PDF)
OHTUVAYRE
  • Active Ingredient(s): Ensifentrine
  • Strength: 3MG/2.5ML
  • Dosage Form(s) / Route(s): Suspension;inhalation
  • Company: Verona Pharma
  • Approval Date: 26 June 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
  • Approved Label:  26 June 2024 (PDF)
PEMETREXED
  • Active Ingredient(s): Pemetrexed
  • Strength: 100MG; 500MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Apotex Inc
  • Approval Date: 28 June 2024
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for:
    • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
    • as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
    • as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
      • Limitations of Use
    • Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
    • initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
  • Approved Label:  28 June 2024 (PDF)
CHEWTADZY
  • Active Ingredient(s): Tadalafil
  • Strength: 5MG; 10MG; 20MG
  • Dosage Form(s) / Route(s): Tablet, Chewable;oral
  • Company: B Better Llc
  • Approval Date: 28 June 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • erectile dysfunction (ED).
    • the signs and symptoms of benign prostatic hyperplasia (BPH).
    • ED and the signs and symptoms of BPH (ED/BPH).
      • Limitations of Use
      If CHEWTADZY is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.
      CHEWTADZY is not indicated for once daily use for ED because dosing is not possible in such patients (the recommended dosage for this indication cannot be achieved with the lowest available strength).
  • Approved Label:  28 June 2024 (PDF)
NYPOZI
  • Active Ingredient(s): Filgrastim-txid
  • Strength: 300MCG/0.5ML; 480MCG/0.8ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Tanvex Biopharma Usa Inc
  • Approval Date: 28 June 2024
  • 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).
    • Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
    • 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:  28 June 2024 (PDF)
PYZCHIVA
  • Active Ingredient(s): Ustekinumab-ttwe
  • Strength: 45MG/0.5ML; 90MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Samsung Bioepis Co Ltd
  • Approval Date: 28 June 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • Adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
    • Adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
    • Adult patients with moderately to severely active Crohn's disease.
    • Adult patients with moderately to severely active ulcerative colitis.
  • Approved Label:  28 June 2024 (PDF)
AHZANTIVE
  • Active Ingredient(s): Aflibercept
  • Strength: 2MG(0.05ML OF 40MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Formycon Ag
  • Approval Date: 28 June 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (AMD).
    • Macular Edema Following Retinal Vein Occlusion (RVO).
    • Diabetic Macular Edema (DME).
    • Diabetic Retinopathy (DR).
  • Approved Label:  28 June 2024 (PDF)
PYZCHIVA
  • Active Ingredient(s): Ustekinumab-ttwe
  • Strength: 130MG/26ML(5MG/ML)
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Samsung Bioepis Co Ltd
  • Approval Date: 28 June 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • Adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
    • Adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
    • Adult patients with moderately to severely active Crohn's disease.
    • Adult patients with moderately to severely active ulcerative colitis.
  • Approved Label:  28 June 2024 (PDF)