Original New Drug Application Approvals by US FDA (01 - 15 February 2022)

16 Feb 2022
Original New Drug Application Approvals by US FDA (01 - 15 February 2022)
New drug applications approved by US FDA as of 01-15 February 2022 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.

FLEQSUVY
  • Active Ingredient(s): Baclofen
  • Strength: 25MG/5ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Azurity
  • Approval Date: 04 February 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases
  • Approved Label: 04 February 2022 (PDF)
ENJAYMO
  • Active Ingredient(s): Sutimlimab-jome
  • Strength: 1,100MG/22ML(50MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Bioverativ Therapeutics Inc
  • Approval Date: 04 February 2022
  • Submission Classification: Not available
  • Indication(s): indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
  • Approved Label: 04 February 2022 (PDF)