Original New Drug Application Approvals by US FDA (16-31 January 2023)

New drug applications approved by US FDA as of 16-31 January 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.

VANCOMYCIN HYDROCHLORIDE

• Active Ingredient(s): Vancomycin Hydrochloride
• Strength: 500MG/VIAL; 1GRAM/VIAL; 5GRAM/VIAL; 10GRAM/VIAL
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Zhejaing Novus Pharmaceuticals Co. Ltd
• Approval Date: 20 January 2023
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated in adult and pediatric patients less than 18 years of age as follows:
  • Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:
    • Septicemia
    • Infective Endocarditis
    • Skin and Skin Structure Infections
    • Bone Infections
    • Lower Respiratory Tract Infections
  • Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of:
    • Clostridioides difficile-associated diarrhea
    • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
  
  Limitations of Use:
  • Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of C. difficile-associated diarrhea and enterocolitis caused by susceptible isolates of Staphylococcus aureus because it is not effective
  • Vancomycin Hydrochloride for Injection administered orally is not approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections because it is not effective.
  
  To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
• Approved Label:  20 January (PDF)

BRENZVVY

• Active Ingredient(s): Bexagliflozin
• Strength: 20MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Theraxosbio Llc
• Approval Date: 20 January 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  
  Limitation of Use: Not recommended in patients with type 1 diabetes mellitus. May increase the risk of diabetic ketoacidosis in these patients.
• Approved Label:  20 January (PDF)

JAYPIRCA

• Active Ingredient(s): Pirtobrutinib
• Strength: 50MG; 100MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Loxo Oncol
• Approval Date: 27 January 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inh bitor.
  
  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.
• Approved Label:  27 January (PDF)

ORSERDU

• Active Ingredient(s): Elacestrant Dihydrochloride
• Strength: EQ 86MG BASE; EQ 345MG BASE
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Stemline Therap
• Approval Date: 27 January 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for:
  • treatment of postmenopausal women or adult men, with ERpositive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
• Approved Label:  27 January 2023 (PDF)

TECHNETIUM TC 99M MERTIATIDE KIT

• Active Ingredient(s): Technetium Tc-99m Mertiatide Kit
• Strength: N/A
• Dosage Form(s) / Route(s): Powder;intravenous
• Company: Jubilant Draximage
• Approval Date: 30 January 2023
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
• Approved Label:  30 January 2023 (PDF)

DAPTOMYCIN

• Active Ingredient(s): Daptomycin
• Strength: 350MG/VIAL; 500MG/VIAL
• Dosage Form(s) / Route(s): Powder;intravenous
• Company: Xellia Pharms Aps
• Approval Date: 30 January 2023
• 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) 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:  30 January 2023 (PDF)