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
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 Label: 01 June 2021 (PDF)
- 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 Label: 04 June 2021 (PDF)
- 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 Label: 04 June 2021 (PDF)
- 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 Label: 07 June 2021 (PDF)
- 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 Label: 07 June 2021 (PDF)
- 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 Label: 10 June 2021 (PDF)
- 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 Label: 10 June 2021 (PDF)
- 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
