Original New Drug Application Approvals by US FDA (01-15 November 2023)

15 Nov 2023
Original New Drug Application Approvals by US FDA (01-15 November 2023)
New drug applications approved by US FDA as of 01-15 November 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.

VOQUEZNA
  • Active Ingredient(s): Vonoprazan Fumarate
  • Strength: 10MG, 20MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Phathom
  • Approval Date: 01 November 2023
  • Submission Classification: NA
  • Indication(s): Indicated:
    • for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
    • to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
    • in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults.
    • in combination with amoxicillin for the treatment of H. pylori infection in adults.
  • Approved Label:  01 November (PDF)
ZITUVIMET
  • Active Ingredient(s): Sitagliptin;metformin Hydrochloride
  • Strength: 50MG;500MG, 50MG;1000MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Zydus Worldwide DMCC
  • Approval Date: 03 November 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
    Limitations of Use:
    • ZITUVIMET is not recommended in patients with type 1 diabetes mellitus.
    • ZITUVIMET has not been studied in patients with a history of pancreatitis.
  • Approved Label:  03 November 2023 (PDF)
FRUZAQLA
  • Active Ingredient(s): Fruquintinib
  • Strength: 1MG, 5MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Takeda Pharms USA
  • Approval Date: 08 November 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
  • Approved Label:  08 November 2023 (PDF)
ZEPBOUND
  • Active Ingredient(s): Tirzepatide
  • Strength: 2.5MG, 5MG, 7.5MG, 10MG, 12.5MG, 15MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Eli Lilly And Co
  • Approval Date: 08 November 2023
  • Submission Classification: NA
  • Indication(s): Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic we ght management in adults with an initial body mass index (BMI) of:
    • 30 kg/m2 or greater (obesity) or
    • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).
    Limitations of Use:
    • Coadministration with other tirzepatide-containing products or any GLP-1 receptor agonist is not recommended.
    • The safety and efficacy of coadministration with other products for weight management have not been established.
    • ZEPBOUND has not been studied in patients with a history of pancreatitis.
  • Approved Label:  08 November 2023 (PDF)
DEFENCATH
  • Active Ingredient(s): Taurolidine And Heparin Sodium
  • Strength: 3ML containing taurolidine 40.5MG/3ML (13.5MG/ML), and heparin 3,000 USP Units/3ML (1,000 USP Units/mL), 5ML containing taurolidine 67.5MG/5ML (13.5MG/ML), and heparin 5,000 USP Units/5ML (1,000 USP Units/mL)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Cormedix Inc
  • Approval Date: 15 November 2023
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.
    Limitations of Use
    The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC. 
  • Approved Label:  15 November 2023 (PDF)
AUGTYRO
  • Active Ingredient(s): Repotrectinib
  • Strength: N/A
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Bristol-myers Squibb Co
  • Approval Date: 15 November 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
  • Approved Label:  15 November 2023 (PDF)