U.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
ST. LOUIS--(BUSINESS WIRE)--Nov. 25, 2013--
(NYSE: MNK) today announced that the U.S. Food and Drug Administration
(FDA) extended the review of the New Drug Application (NDA) for
investigational compound XARTEMIS™ XR (oxycodone
hydrochloride and acetaminophen) Extended-Release Tablets (CII).
XARTEMIS XR, previously known as MNK-795, was studied for the management
of moderate to severe acute pain where the use of an opioid analgesic is
The three-month extension from the FDA is in response to additional data
submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will
continue discussions regarding labeling as part of the application
review throughout this period.
“If approved, we believe that XARTEMIS XR could provide an important new
option as an extended-release treatment for patients with acute pain,”
said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt.
“As a leader in pain management, Mallinckrodt remains committed to
developing medications that address the needs of patients, and will work
with the FDA throughout the review of the XARTEMIS XR application.”
XARTEMIS XR, an investigational, extended-release oral formulation of
oxycodone and acetaminophen uses a dual layer delivery mechanism with
both immediate- and extended-release components. In July, the FDA
accepted for filing the NDA for XARTEMIS XR and granted priority review.
There are currently no extended-release oxycodone/acetaminophen
combinations on the market for the management of acute pain.
Mallinckrodt is a global specialty pharmaceutical business that
develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. The company’s Specialty
Pharmaceuticals segment includes branded and generic drugs and active
pharmaceutical ingredients, and the Global Medical Imaging segment
includes contrast media and nuclear imaging agents. Mallinckrodt has
approximately 5,500 employees worldwide and a commercial presence in
roughly 70 countries. The company’s 2013 revenue totaled $2.2 billion.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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Lynn Phillips, 314-654-3263
Senior Vice President, Communications
Vice President, Investor Relations