Original New Drug Application Approvals by US FDA (16-29 February 2024)

06 Mar 2024
Original New Drug Application Approvals by US FDA (16-29 February 2024)
New drug applications approved by US FDA as of 16-29 February 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.

EXBLIFEP
  • Active Ingredient(s): Cefepime;enmetazobactam
  • Strength: 2.5G(2G;0.5G)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Allecra Therapeutics Sas
  • Approval Date: 22 February 2024
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of EXBLIFEP and other antibacterial drugs, EXBLIFEP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • Approved Label:  22 February 2024 (PDF)
SIMLANDI
  • Active Ingredient(s): Adalimumab-ryvk
  • Strength: 40MG/0.4ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Alvotech Usa Inc
  • Approval Date: 23 February 2024
  • Submission Classification: Not Available
  • Indication(s):Indicated for:
    • Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
    • Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
    • Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
    • Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
    • Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
    • Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients.

      • Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
    • Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
    • Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients
    • Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients
  • Approved Label:  23 February 2024 (PDF)
LETYBO
  • Active Ingredient(s): Letibotulinumtoxina-wlbg
  • Strength: 0.1ML(4UNITS)
  • Dosage Form(s) / Route(s): Powder, For Solution
  • Company: Hugel Inc
  • Approval Date: 29 February 2024
  • Submission Classification:  Not Available
  • Indication(s): Indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
  • Approved Label:  29 February 2024 (PDF)