Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Actavis Receives FDA Approval For Generic Opana® ER

RELATED NEWS
Trade ACT now with 

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generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.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

Click here to receive FREE breaking news email alerts for Actavis Plc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Two federal appeals courts have issued contradictory rulings over the federal government's ability to provide subsidies under Obamacare, suggesting that the future of President Barack Obama's healthcare law could once again end up in the hands of the U.S. Supreme Court. After ending the previous session modestly lower, stocks have shown a strong move back to the upside during trading on Tuesday. With the upward move on the day, the S&P 500 has reached a new record intraday high. A majority of Americans believe Israel is justified in taking military action against Gaza, according to the results of a new CNN/ORC International survey, although opinions about the amount of military force the Israelis have used are more divided.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.