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

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

KERENDIA

• Active Ingredient(s): Finerenone
• Strength: 10MG; 20MG
• Dosage Form(s) / Route(s): Tablet; Oral
• Company: Bayer Healthcare Pharms
• Approval Date: 09 July 2021
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
• Approved Label: 09 July 2021 (PDF)