U.S. FDA Announces Joint Advisory Committee Review of Mallinckrodt's Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)
Published: Oct 08, 2018
-- Company Seeks Approval of New Drug Application for MNK-812 Through 505(b)2 Regulatory Pathway --
STAINES-UPON-THAMES, United Kingdom, Oct. 8, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has confirmed it will hold a joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on Nov. 14, 2018.
The Committees will assess the 505(b)2 new drug application submission for MNK-812, Mallinckrodt's abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets with a proposed indication for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Mallinckrodt is advancing this reformulation of Roxicodone® (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse.
"We look forward to engaging with the Advisory Committees to discuss the potential benefits our new abuse-deterrent formulation technology can bring in helping to mitigate opioid abuse and misuse," said Matt Harbaugh, Executive Vice President, Chief Financial Officer and President, Specialty Generics for Mallinckrodt.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 16, 2018, to complete its review of Mallinckrodt's product.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Included within the company's discontinued operations, the Specialty Generics business includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning MNK-812 including expectations with regard to future regulatory actions and 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; future commercialization efforts; 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.
Senior Communications Manager
Chief Public Affairs Officer
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
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SOURCE Mallinckrodt plc
Company Codes: NYSE:MNK