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generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.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

Editors Pick
Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Stocks moved notably higher over the course of the trading day on Monday, extending the strong upward move seen last Friday. The gains on the day continued the recent recovery by the markets, with the Nasdaq and the S&P 500 closing higher for the third consecutive session. While Republicans have largely tried to frame the upcoming midterm elections as a referendum on President Barack Obama, Sen. Ted Cruz, R-Tex., has joined the few offering guidance on what the GOP will do if it manages to retake control of the Senate.
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.