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

06 Dec 2024
Original New Drug Application Approvals by US FDA (16-30 November 2024)
New drug applications approved by US FDA as of 16-30 November 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.

ZIIHERA
  • Active Ingredient(s): Zanidatamab-hrii
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Jazz Pharms
  • Approval Date: 20 November 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  20 November 2024 (PDF)
DAPTOMYCIN
  • Active Ingredient(s): Daptomycin
  • Strength: 350MG/VIAL; 500MG/VIAL
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Maia Pharms Inc
  • Approval Date: 21 November 2024
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of:
    • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,
    • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis,
    • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age).
      Limitations of Use:
    • Daptomycin for Injection is not indicated for the treatment of pneumonia.
    • Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus.
    • Daptomycin for Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  21 November 2024 (PDF)
ATTRUBY
  • Active Ingredient(s): Acoramidis
  • Strength: 712MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Bridgebio Pharma Inc
  • Approval Date: 22 November 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascularrelated hospitalization.
  • Approved Label:  22 November 2024 (PDF)
RAPIBLYK
  • Active Ingredient(s): Landiolol
  • Strength: 280MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Aop Orphan Pharmaceuticals Gmbh
  • Approval Date: 22 November 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
  • Approved Label:  22 November 2024 (PDF)
IMKELDI
  • Active Ingredient(s): Imatinib
  • Strength: 80MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Shorla
  • Approval Date: 22 November 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
    • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
    • Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
    • Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
    • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
    • Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
    • Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.
    • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
    • Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
    • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.
  • Approved Label:  22 November 2024 (PDF)
RALDESY
  • Active Ingredient(s): Trazodone Hydrochloride
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Kamat Pharmatech, Llc
  • Approval Date: 26 November 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of major depressive disorder (MDD) in adults.
  • Approved Label:  26 November 2024 (PDF)
IOMERVU
  • Active Ingredient(s): Iomeprol
  • Strength: 250MG/ML; 300MG/ML; 350MG/ML; 400MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Bracco Diagnostics Inc
  • Approval Date: 27 November 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for:
      • Intra-arterial Procedures
    • Cerebral arteriography, including intra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients
    • Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients
    • Coronary arteriography and cardiac ventriculography in adults
    • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients
      Intravenous Procedures
    • Computed tomography (CT) of the head and body in adults and pediatric patients
    • CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients
    • Coronary CT angiography in adults and pediatric patients
    • CT urography in adults and pediatric patients
  • Approved Label:  27 November 2024 (PDF)
YESINTEK
  • Active Ingredient(s): Ustekinumab-kfce
  • Strength: 45MG/0.5ML; 90MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Biocon Biologics Inc
  • Approval Date: 29 November 2024
  • Submission Classification:NA
  • Indication(s): Indicated for the treatment of:
      • Adult patients with:
    • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA). <li>moderately to severely active Crohn’s disease (CD). </li
    • moderately to severely active ulcerative colitis.
      Pediatric patients 6 years and older with:
    • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA).
  • Approved Label:  29 November 2024 (PDF)