Regulatory Affairs

Actavis wins FDA approval for ANDA of generic Opana ER

PBR Staff Writer Published 15 July 2013

Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER.

Oxymorphone Hydrochloride extended-release tablets, which is available in doses 5mg, 10mg, 20mg, 30mg and 40mg, is the ANDA product indicated for the relief of moderate to severe pain in patients who need continuous opioid treatment for an extended period of time.

Opana ER is an opioid agonist that was previously marketed and was voluntarily withdrawn from sale in 2012.

Total US sales of Opana ER tablets were approximately $461m for the 12 months ending on 31 May 2013, according to IMS Health data.

The company had earlier received approval and is currently marketing Oxymorphone Hydrochloride extended-release tablets 7.5mg and 15mg for which it is currently defending ongoing patent litigation that was initiated by Endo.