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

02 Aug 2021
New drug applications approved by US FDA as of 16-31 July 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.

FEXINIDAZOLE
  • Active Ingredient(s): Fexinidazole
  • Strength: 600MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: DNDI
  • Approval Date: 16 July 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.
  • Approved Label16 July 2021 (PDF)
REZUROCK
  • Active Ingredient(s): Belumosudil Mesylate
  • Strength: EQ 200MG BASE
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Kadmon Pharms LLC
  • Approval Date: 16 July 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
  • Approved Label16 July 2021 (PDF)
BYLVAY
  • Active Ingredient(s): Odevixibat
  • Strength: 400MCG; 1200MCG; 200MCG; 600MCG
  • Dosage Form(s) / Route(s): Capsule; Oral ; Pellets; Oral
  • Company: Albireo Pharma Inc
  • Approval Date: 20 July 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
  • Approved Label20 July 2021 (PDF)
TWYNEO
  • Active Ingredient(s): Tretinoin; Benzoyl Peroxide
  • Strength: 0.1%; 3%
  • Dosage Form(s) / Route(s): Cream; Topical
  • Company: Sol-gel Technologies Ltd
  • Approval Date: 26 July 2021
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
  • Approved Label26 July 2021 (PDF)
SEMGLEE
  • Active Ingredient(s): Insulin Glargine-YFGN
  • Strength:10ML(100UNITS/ML); 3ML(100UNITS/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Mylan Pharms Inc
  • Approval Date: 28 July 2021
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
  • Approved Label28 July 2021 (PDF)
UPTRAVI
  • Active Ingredient(s): Selexipag
  • Strength: 200MCG; 400MCG; 600MCG; 800MCG; 1000MCG; 1200MCG; 1400MCG; 1600MCG; 1800MCG
  • Dosage Form(s) / Route(s): Tablet; Oral; Injectable; Injection
  • Company: Actelion
  • Approval Date: 29 July 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):Not available
  • Approved Label: Not available
SAPHNELO
  • Active Ingredient(s): Anifrolumab-FNIA
  • Strength: 300MG/2ML(150MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Astrazeneca AB
  • Approval Date: 30 July 2021
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available

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