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news.Endo Pharmaceuticals has reported that the FDA has approved three new dosage strengths of Opana extended-release or Opana ER tablets CII.
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The new strengths, 7.5mg, 15mg, and 30mg, will be available on April 1, 2008 and will join previously approved Opana ER dosage strengths of 5mg, 10mg, 20mg, and 40mg. An opioid analgesic, Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
David Lee, chief scientific officer of Endo, said: “The addition of three new dosage strengths of Opana ER, complementing the currently available strengths, will make it easier for physicians to titrate patients to the optimal level of pain relief. The new strengths will also facilitate clinicians’s ability to convert patients to Opana ER from other opioid analgesics to which they may not have had an adequate clinical response.”