Original New Drug Application Approvals by US FDA (16-31 October 2024)
07 Nov 2024
New drug applications approved by US FDA as of 16-31 October 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.
VYALEV
VYALEV
- Active Ingredient(s): Foscarbidopa And Foslevodopa
- Strength: 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
- Dosage Form(s) / Route(s): Solution;subcutaneous
- Company: Abbvie
- Approval Date: 16 October 2024
- Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
- Indication(s): Indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
- Approved Label: 16 October 2024 (PDF)
- Active Ingredient(s): Zolbetuximab-clzb
- Strength: 100MG
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Astellas
- Approval Date: 18 October 2024
- Submission Classification: NA
- Indication(s): Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
- Approved Label: 18 October 2024 (PDF)
- Active Ingredient(s): Docetaxel
- Strength: 80MG/4ML (20MG/ML)
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Zhuhai
- Approval Date: 23 October 2024
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
- Approved Label: 23 October 2024 (PDF)
- Active Ingredient(s): Sulopenem Etzadroxil;probenecid
- Strength: 500MG;500MG
- Dosage Form(s) / Route(s): Tablet
- Company: Iterum Therapeutics Us Ltd
- Approval Date: 25 October 2024
- Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
- Indication(s): Indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
- Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI.
- Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous antibacterial treatment of cIAI.
- Approved Label: 25 October 2024 (PDF)
- Limitations of Use:
ORLYNVAH is not indicated for the treatment of:
- Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH and other antibacterial drugs, ORLYNVAH should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy