Original New Drug Application Approvals by US FDA (01 - 15 June 2021)

15 Jun 2021
New drug applications approved by US FDA as of 01-15 June 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.

BREXAFEMME
  • Active Ingredient(s): Ibrexafungerp Citrate
  • Strength: EQ 150MG BASE
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Scynexis, Inc
  • Approval Date: 01 June 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC)
  • Approved Label01 June 2021 (PDF)
TEMBEXA
  • Active Ingredient(s): Brincidofovir
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Tablet; Oral Suspension
  • Company: Chimerix
  • Approval Date: 04 June 2021
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. 
  • Approved Label04 June 2021 (PDF)
WEGOVY
  • Active Ingredient(s): Semaglutide
  • Strength: 0.25MG; 0.5MG; 1MG; 1.7MG; 2.4MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Novo Nordisk Inc
  • Approval Date: 04 June 2021
  • Submission Classification: Not available
  • Indication(s): Indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 
    • 30 kg/m2 or greater (obesity) or
    • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)   
  • Approved Label04 June 2021 (PDF)
ARGATROBAN
  • Active Ingredient(s): Argatroban
  • Strength: 50MG/50ML (1MG/ML)
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Accord Hlthcare Inc
  • Approval Date: 07 June 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:-
    • For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT)
    • As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI)
  • Approved Label07 June 2021 (PDF)
ADUHELM
  • Active Ingredient(s): Aducanumab-avwa
  • Strength: 170MG/1.7ML (100MG/ML); 300MG/3ML (100MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Biogen Inc
  • Approval Date: 07 June 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Alzheimer’s disease.
  • Approved Label07 June 2021 (PDF)
EPCLUSA
  • Active Ingredient(s): Sofosbuvir; Velpatasvir
  • Strength: 200;50MG; 150;37.5MG
  • Dosage Form(s) / Route(s): Pellets; Oral
  • Company: Gilead Sciences Inc
  • Approval Date: 10 June 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection:-
    • without cirrhosis or with compensated cirrhosis
    • with decompensated cirrhosis for use in combination with ribavirin
  • Approved Label10 June 2021 (PDF)
SODIUM PHENYLACETATE; SODIUM BENZOATE
  • Active Ingredient(s): Sodium Phenylacetate; Sodium Benzoate
  • Strength: 10%
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: MAIA Pharms Inc
  • Approval Date: 10 June 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiencies in enzymes of the urea cycle.
  • Approved Label10 June 2021 (PDF)
MAVYRET
  • Active Ingredient(s): Glecaprevir; Pibrentasvir
  • Strength: 100MG;40MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Abbvie Inc
  • Approval Date: 10 June 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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