FDAnews Drug Daily Bulletin

Endo Readies New Opana ER Dosages for the Market

March 12, 2008

Endo Pharmaceuticals plans to launch three new dosage strengths of opioid analgesic Opana ER April 1. The new strengths — 7.5, 15 and 30 mg — will join previously approved Opana ER (oxymorphone HCl) dosages of 5, 10, 20 and 40 mg.

Endo said the dosages would help clinicians convert patients from other opioid analgesics that had not proven effective for them.

The FDA’s approval of the new strengths is based on studies demonstrating the safety and efficacy of the drug’s four original strengths. Because the new dosages fall between the available strengths, the agency did not require new safety or efficacy studies.