Opana FDA Approval History
Last updated by Judith Stewart, BPharm on June 9, 2020.
FDA Approved: Yes (Discontinued) (First approved June 22, 2006)
Brand name: Opana
Generic name: oxymorphone
Dosage form: Tablets and ER Tablets
Company: Endo Pharmaceuticals Inc.
Treatment for: Pain
Marketing Status: Discontinued
Opana (immediate-release) and Opana ER (extended-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana is indicated for the relief of acute pain where the use of an opioid is appropriate, and Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
Development Timeline for Opana
|Dec 12, 2011||Approval Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant|
|Jun 22, 2006||Approval Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain|
|Dec 22, 2005||Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets|
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