FDA approves Impax's ANDA for generic OPANA ER 30mg tablet
Published on July 23, 2010 at 1:45 AM
Impax Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.
As previously announced, in June 2010, the Company reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals to grant the Company a license to sell a generic of OPANA® ER on Jan. 1, 2013 or earlier under certain circumstances.
The Company was the first to file a paragraph IV certification on these strengths and will be entitled to 180 days of market exclusivity upon product launch. Global Pharmaceuticals, Impax's generic division will commercialize the product on Jan. 1, 2013 or earlier under certain circumstances.
Endo Pharmaceuticals and Penwest Pharmaceuticals manufacture and market OPANA® ER for the treatment of moderate to severe pain. According to Wolters Kluwer Health, U.S. sales of OPANA® ER tablets were approximately $254 million for the 12 months ended May 31, 2010.