Finerenone (Kerendia)

Context United States FDA original approval of a new drug application (NDA)

Recipient

Recipient not specified

Population

Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.

Care setting

Not stated in the FDA records

Geography

United States (decision by the US Food and Drug Administration)

Life stage

Not stated in the FDA records

Gestational age

Not reported

Postnatal age

Not reported

Follow-up

Not applicable (regulatory decision)

• Regulatory Evidence stage not applicable Certainty not assessed

  The US Food and Drug Administration approved Kerendia (finerenone tablets) on 9 July 2021 under new drug application NDA215341. The Drugs@FDA page lists the original submission as ORIG-1, an approval, classified Type 1 - New Molecular Entity. The openFDA record lists the applicant as BAYER HLTHCARE.

  Applies to Recipient not specified

  • Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory decision)

  Certainty method

  Not assessed

  Limitations

  An FDA approval is a decision about a medicine, not a finding about how much it helps any person. The date comes from the Drugs@FDA page, which writes it as a month-first slash date. The openFDA record gives the date only as a compact number, so the page is quoted. No label record for Kerendia was returned by openFDA, so this atlas states no indication. openFDA says not to rely on it for decisions about medical care.

  Last checked

  2026-10-14

  Next evidence check due

  Not scheduled

  Sources and citations (4)

  1. Supports FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record for application NDA215341 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot. · NDA: NDA215341

     Locator

     results[0].application_number; results[0].sponsor_name

     How it applies

     Application number and applicant.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215341.json.

  2. Supports Drugs@FDA: approval date(s) and history for NDA 215341 (Kerendia)

     Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14.

     Locator

     Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY)

     How it applies

     Original approval date.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     1dbf2f78139897b5d65087d562dd452e07f39893a5c534b4c76ec8b0b669d490

     Reuse basis

     The FDA website policies page (fetched 2026-10-14 as ch-fda-website-policies.html, sha256 59b7c8541753, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The raw page is committed at research/snapshots/ch-fda-daf-nda215341.html.

  3. Supports FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record for application NDA215341 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot. · NDA: NDA215341

     Locator

     results[0].submissions[3].submission_type; results[0].submissions[3].submission_status; results[0].submissions[3].submission_class_code_description

     How it applies

     Original submission, its status and classification.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215341.json.

  4. Background FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record for application NDA215341 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot. · NDA: NDA215341

     Locator

     results[0].products[0].active_ingredients[0].name

     How it applies

     Active ingredient on the application record.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215341.json.