logo
Share SHARE
FONT-SIZE Plus   Neg

Actavis Receives FDA Approval For Generic Opana® ER

Actavis, Inc. (ACT) announced that it has received approval from the U.S. Food and Drug Administration or FDA on its Abbreviated New Drug Application or ANDA for Oxymorphone Hydrochloride Extended-release Tablets, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.

Actavis said its ANDA product is the generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.

Actavis stated that it previously received approval for, and is currently marketing, Oxymorphone Hydrochloride Extended-release Tablets 7.5 mg and 15 mg.

The company is currently defending ongoing patent litigation initiated by Endo concerning the 7.5 mg and 15 mg Tablets, and is still evaluating launch plans for the additional dosage strengths at this time.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Delta Air Lines Inc. (DAL) pilots, represented by the Air Line Pilots Association International, are picketing on Friday at several airports across the country. The pilots said the picketing was to raise the sense of urgency in ongoing contract negotiations. The negotiations between the pilots... Charter Communications, and its recently acquired subsidiary Time Warner Cable, have been regularly overcharging its consumers to a tune of $7.2 million per year, according to a report from the U.S. Senate's Permanent Subcommittee on Investigations. According to the report, Time Warner Cable over-billed... Popular photo sharing network Instagram is adding a new translation button on its pages, so that the global crowd can read and enjoy the captions and comments given for the photographs uploaded. The new update will be available from next month onward.
comments powered by Disqus
Follow RTT