Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced the resubmission of the Company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) .
| DUBLIN, June 13, 2022 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced the resubmission of the Company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition2 for which there is currently no FDA-approved treatment.3
Terlipressin is an investigational agent being evaluated for the treatment of HRS in the U.S., and its safety and effectiveness have not yet been established by the FDA. The resubmission follows ongoing discussions with the FDA resulting from a Complete Response Letter (CRL) received on February 18, 2022. In the two weeks prior to the PDUFA date of February 18, 2022, it became necessary to identify a new third-party packaging and labeling facility. While Mallinckrodt identified a new facility, an FDA inspection of the facility could not be completed by the February PDUFA date, resulting in the receipt of the CRL. For the NDA to be approved, the new facility must be inspection ready at the time of filing. This was the only outstanding issue noted in the CRL, as there were no safety or efficacy issues cited. 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 U.S. for more than 30 years, is available on five continents, and is considered the standard of care for its two indications in the countries where it is approved.5,6,7 ABOUT MALLINCKRODT Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS CONTACT Media Inquiries Investor Relations Derek Belz Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2022 Mallinckrodt. US-2200445 06/22 References
SOURCE Mallinckrodt plc | ||||||||||||||||||
Company Codes: OTC-BB:MNKKQ, OTC-PINK:MNKKQ, OtherOTC:MNKKQ | ||||||||||||||||||
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