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

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

COSENTYX
  • Active Ingredient(s): Secukinumab
  • Strength: 150MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Novartis Pharms Corp
  • Approval Date: 06 October 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
    • active psoriatic arthritis (PsA) in patients 2 years of age and older.
    • adults with active ankylosing spondylitis (AS).
    • adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
    • active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. 
  • Approved Label: 06 October (PDF)
VELSIPITY
  • Active Ingredient(s): Etrasimod
  • Strength: 2MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Pfizer Inc
  • Approval Date: 12 October 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of moderately to severely active ulcerative colitis in adults. 
  • Approved Label: 12 October (PDF)