Terlipressin is an investigational agent being evaluated for the treatment of HRS in the
The resubmission follows ongoing discussions with the FDA resulting from a Complete Response Letter (CRL) received on
Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.4 It has been approved outside the
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to terlipressin, including related to interactions with regulators, steps being taken related to its manufacturing, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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© 2022 Mallinckrodt. US-2200445 06/22
Data on File – Ref-05737. Mallinckrodt Pharmaceuticals
Belcher, et al. Terlipressin and the Treatment of Hepatorenal Syndrome: How the CONFIRM Trial Moves the Story Forward. Am J Kidney Dis. 2022;79(5):737-745. doi:10.1053/j.ajkd.2021.08.016
Data on File – Ref-05488. Mallinckrodt Pharmaceuticals
Data on File – Ref-05482. Mallinckrodt Pharmaceuticals
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