Rolling Submission of New Drug Application to FDA for Terlipressin for Hepatorenal Syndrome Type 1 Initiated
Mallinckrodt plc a global biopharmaceutical company, announced it initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being investigated for the treatment of hepatorenal syndrome type 1 (HRS-1), by submitting its clinical data package. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.1 The company expects to complete the submission of the NDA in the coming months.
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1 U.S. Food and Drug Administration. “Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.” Available at https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf. Accessed February 6, 2020.