New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

1. Fexinidazole Tablets

Company: Drugs for Neglected Diseases Initiative
Date of Approval: July 16, 2021
Treatment for: Trypanosomiasis

Fexinidazole is a nitroimidazole antibacterial indicated for the treatment of human African trypanosomiasis (African sleeping sickness) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

2. Kerendia (finerenone) Tablets

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: July 9, 2021
Treatment for: Chronic Kidney Disease Associated with Type 2 Diabetes

Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

3.Astepro Allergy (Azelastine) Nasal Spray

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: June 17, 2021
Treatment for: Allergic Rhinitis

Astepro Allergy (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

4.Wegovy (Semaglutide) Injection

Company: Novo Nordisk
Date of Approval: June 4, 2021
Treatment for: Obesity

Wegovy (semaglutide) is a Glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise for chronic weight management in adult patients who are overweight (BMI ≥27 kg/m2) or obese (BMI ≥30 kg/m2).

5.Tembexa (brincidofovir) Tablets and Oral Suspension

Company: Chimerix, Inc.
Date of Approval: June 4, 2021
Treatment for: Smallpox

Tembexa (brincidofovir) is a nucleotide analog broad-spectrum antiviral indicated for use as a medical countermeasure for smallpox.

6.Lumakras (sotorasib) Tablets

Company: Amgen Inc.
Date of Approval: May 28, 2021
Treatment for: Non-Small Cell Lung Cancer

Lumakras (sotorasib) is a KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following at least one prior systemic therapy.

7.Truseltiq (infigratinib) Capsules

Company: BridgeBio Pharma, Inc.
Date of Approval: May 28, 2021
Treatment for: Cholangiocarcinoma

Truseltiq (infigratinib) is an FGFR tyrosine kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.