Original New Drug Application Approvals by US FDA (16 - 30 September 2020)

01 Oct 2020
Original New Drug Application Approvals by US FDA (16 - 30 September 2020)
New drug applications approved by US FDA as of 16 - 30 September 2020 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.

XELJANZ
  • Active Ingredient(s): Tofacitinib
  • Strength: 5 mg
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Pfizer, Inc.
  • Approval Date: 25 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Rheumatoid Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
    • Psoriatic Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
    • Ulcerative Colitis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
    • Polyarticular Course Juvenile Idiopathic Arthritis: XELJANZ/XELJANZ XR Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
  • Approved Label: 25 September 2020 (PDF)

ALKINDI SPRINKLE
  • Active Ingredient(s): Hydrocortisone
  • Strength: 0.5 mg; 1 mg; 2.5 mg; 5 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Diurnal Ltd.
  • Approval Date: 29 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.
  • Approved Label: 29 September 2020 (PDF)

ATROPINE SULFATE
  • Active Ingredient(s): Atropine sulfate
  • Strength: 0.4 mg/mL; 1 mg/mL
  • Dosage Form(s) / Route(s): Solution; injection
  • Company: Accord Healthcare
  • Approval Date: 29 September 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for temporary blockade of severe or life threatening muscarine effects.
  • Approved Label: 29 September 2020 (PDF)