Original New Drug Application Approvals by US FDA (16-31 August 2021)

02 Sep 2021
New drug applications approved by US FDA as of 16-31 August 2021 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.

JEMPERLI
  • Active Ingredient(s): Dostarlimab-gxly
  • Strength: 500MG/10ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Glaxosmithkline LLC
  • Approval Date: 17 August 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced:
    • endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or
    • solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
  • Approved Label17 August 2021 (PDF)
SUCCINYLCHOLINE CHLORIDE
  • Active Ingredient(s): Succinylcholine Chloride
  • Strength: 100MG/5ML (20MG/ML)
  • Dosage Form(s) / Route(s): Solution; Intramuscular, Intravenous
  • Company: Hikma Pharms
  • Approval Date: 20 August 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults and pediatric patients:
    • as an adjunct to general anesthesia
    • to facilitate tracheal intubation
    • to provide skeletal muscle relaxation during surgery or mechanical ventilation
  • Approved Label20 August 2021 (PDF)
KORSUVA
  • Active Ingredient(s): Difelikefalin Acetate
  • Strength: 65MCG/1.3ML (50MCG/ML)
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Cara Therapeutics Inc
  • Approval Date: 23 August 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
  • Approved Label23 August 2021 (PDF)
CYCLOPHOSPHAMIDE
  • Active Ingredient(s): Cyclophosphamide
  • Strength: 500MG/2.5ml (200MG/ML); 1GM/5ML (200MG/ML)
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Auromedics Pharma
  • Approval Date: 25 August 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
SKYTROFA
  • Active Ingredient(s): Lonapegsomatropin-tcgd
  • Strength: 3MG; 3.6MG; 4.3MG; 5.2MG; 6.3MG; 7.6MG; 9.1MG; 11MG; 13.3MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Acendis Pharma Endocrinology Div A/S
  • Approval Date: 25 August 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • Approved Label25 August 2021 (PDF)
VANCOMYCIN
  • Active Ingredient(s): Vancomycin
  • Strength: 5G/100ML
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Xellia Pharms Aps
  • Approval Date: 26 August 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
LOREEV XR
  • Active Ingredient(s): Lorazepam
  • Strength:1MG; 2MG; 3MG
  • Dosage Form(s) / Route(s): Capsule, Extended Release; Oral
  • Company: Almatica Pharma, LLC
  • Approval Date: 27 August 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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