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Landiolol FDA Approval Status

FDA Approved: No
Generic name: landiolol
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Supraventricular Tachycardia

Landiolol is an ultra-short acting cardioselective beta-1 adrenergic blocker in development for the management of tachycardia in the critical care setting.

  • Beta-1 adrenergic blockers are used frequently in critical care settings to manage tachycardia, but can have the unwanted effects of decreasing the contractility of the heart, and of lowering blood pressure. As a cardioselective beta-1 adrenergic blocker, landiolol works to reduce heart rate with minimal effect over cardiac contractility (inotropy) and minimal impact on blood pressure.
  • Landiolol is already commercially available in Japan (Onoact®) and several European markets (Rapibloc®).
  • The submission of the New Drug Application to the U.S. Food and Drug Administration seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.

Development timeline for landiolol

DateArticle
Jun  1, 2022Eagle Pharmaceuticals Announces Submission of New Drug Application to U.S. Food and Drug Administration for Landiolol, a Beta-1 Adrenergic Blocker
Jan 31, 2022Eagle Pharmaceuticals on Track to Support Submission of New Drug Application in Second Quarter 2022 for Landiolol, a Beta-1 Adrenergic Blocker

Further information

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