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Terlipressin FDA Approval Status

FDA Approved: No
Generic name: terlipressin
Dosage form: for Injection
Company: Mallinckrodt plc
Treatment for: Hepatorenal Syndrome Type 1

Terlipressin is a synthetic vasopressin analogue in development for the treatment of hepatorenal syndrome (HRS) Type 1.

Development Timeline for terlipressin

DateArticle
Sep 14, 2020Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
Jul 15, 2020Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
Apr 22, 2020Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
Mar 17, 2020Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
Mar  2, 2020Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
Mar 30, 2010Ikaria Acquires New Drug Application for Lucassin
Jun 12, 2009FDA Accepts Final Section of NDA Filing for Lucassin

Further information

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