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)