FDA approvals and recalls

Cardiovascular: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

3 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Myqorzo (aficamten)

    Approved for: MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. MYQORZO is a cardiac…

    NDA219083

  • Attruby (acoramidis hydrochloride)

    Approved for: ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and card…

    NDA216540

  • Inpefa (sotagliflozin)

    Approved for: INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes…

    NDA216203

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

28 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

907 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

61 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

52,674 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Nausea2,541 reports
  2. 2Dyspnoea2,448 reports
  3. 3Dizziness2,358 reports
  4. 4Hypotension2,176 reports
  5. 5Acute kidney injury2,095 reports
  6. 6Fatigue2,086 reports
  7. 7Diarrhoea1,851 reports
  8. 8Cardiac failure1,766 reports
  9. 9Paraesthesia1,556 reports
  10. 10Vomiting1,544 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on cardiovascular

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