Mylan Launches Generic Version of Roxicodone Tablets

Mylan MYL today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Oxycodone Hydrochloride Tablets USP, 5 mg, 15 mg and 30 mg, based on a development and supply agreement with Coastal Pharmaceuticals. This product is the generic version of Xanodyne's Roxicodone®, a treatment for moderate to severe pain. Oxycodone HCI Tablets had U.S. sales of approximately $325 million for the 12 months ending March 31, 2011, according to IMS Health. Currently, Mylan has 167 ANDAs pending FDA approval representing $100.3 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.
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