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# Mallinckrodt ‘Complete Response’ on Terlipressin NDA
- URL: https://www.fdaweb.com/mallinckrodt-complete-response-on-terlipressin-nda/
- Published: 2022-02-23T12:00:00.000Z
- Updated: 2026-09-14T17:33:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151225

FDA has again issued Mallinckrodt a Complete Response Letter on its NDA for terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening condition involving rapid reduction in kidney function. “Within the last two weeks, it became necessary to identify a new packaging and labeling manufacturing facility which meant that an inspection of the new facility by the FDA could not be completed by the \[user fee\] date,” the company says. “This is the only outstanding issue noted in the CRL, and it is important to note that there were no safety or efficacy issues cited.” In 9/2020, the agency issued a CRL letter that said the NDA was not approvable in its current form and required more information to support a positive risk-benefit profile ([see earlier story](https://www.fdaweb.com/fda-turns-down-mallinckrodt-nda-for-terlipressin/)).

Mallinckrodt says it is working with the new facility to have it ready for inspection, adding that it believes that there is a path to approval in 2022.

Terlipressin is a potent vasopressin analog selective for V1 receptors, according to Mallinckrodt. It describes HRS-1 as an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. It has a median survival time of about two weeks and greater than 80% mortality within three months if left untreated, it says. It is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.