ST. LOUIS, Mo. – November 5, 2013 - Mallinckrodt (NYSE:MNK), a global specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval of the name XARTEMIS™ XR (oxycodone and acetaminophen) Extended-Release Tablets for the New Drug Application (NDA) filed as MNK-795. This name may be applied to the product if the agency grants approval for the drug. XARTEMIS XR is an investigational, extended-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. In July, 2013, the FDA accepted for filing the NDA for XARTEMIS XR and granted priority review.
“We are pleased that the FDA has chosen to conditionally accept the name XARTEMIS XR for the drug filed as MNK-795,” said Mario Saltarelli, MD, PhD, Senior Vice President and Chief Scientific Officer of Mallinckrodt. “We look forward to working further with the agency on the NDA submission in anticipation of their response.”
Mallinckrodt is a global specialty pharmaceuticals 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 the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide with sales in roughly 70 countries. To learn more about Mallinckrodt, please visit www.mallinckrodt.com.
Vice President, Investor Relations