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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, 2011Approval Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant
Jun 22, 2006Approval Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain
Dec 22, 2005Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets

Further information

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