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

19 Jan 2022
Original New Drug Application Approvals by US FDA (01 - 15 January 2022)
New drug applications approved by US FDA as of 01-15 January 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.

QUVIVIQ
  • Active Ingredient(s): Daridorexant
  • Strength: 25MG; 50MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Idorsia Pharmaceuticals Ltd.
  • Approval Date: 07 January 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. 
  • Approved Label: 07 January 2022 (PDF)
RYALTRIS
  • Active Ingredient(s): Olopatadine Hydrochloride And Mometasone Furoate Monohydrate
  • Strength: 665MCG/25MCG
  • Dosage Form(s) / Route(s): Spray, Metered; Nasal
  • Company: Glenmark Specialty Sa
  • Approval Date: 13 January 2022
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.
  • Approved Label: 13 January 2022 (PDF)