Original New Drug Application Approvals by US FDA (16 - 31 July 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 Label: 16 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 Label: 16 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 Label: 20 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 Label: 26 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 Label: 28 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