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ARTICLE | Company News

FDA may block generic Opana sales

November 3, 2017 5:43 PM UTC

FDA is considering taking regulatory action to prevent the marketing of products containing oxymorphone, such as Opana ER oxymorphone extended release from Endo International plc (NASDAQ:ENDP), FDA Commissioner Scott Gottlieb announced Friday.

In a speech to the National Press Club, Gottlieb noted “media reports in recent days that stated that Endo is participating in a re-launch of the old version of Opana ER” which the company has withdrawn from the market. He was referring to reports that Endo will receive royalties on sales of a generic form of Opana ER from Impax Laboratories Inc. (NASDAQ:IPXL)...