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the generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.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
Cloud-based human resource software maker Workday, Inc. said Monday after the markets closed that its third quarter net loss widened from last year, as higher costs and expenses more than offset a 68% increase in revenue. However, the company's adjusted loss per share was smaller than what analysts estimated and its quarterly revenue topped analysts' forecast. This apparel maker has doubled its earnings per share in just two years and increased its annual earnings forecast from time to time, despite a challenging consumer spending environment. Contributions from acquisitions, efficiency gains from self-owned global supply chain and benefits from 'Innovate-to-Elevate' strategy continue to boost the company's results. Here is a quick summary of the earnings reported after the bell on Nov 20. We have 20+ stocks listed here. The good news is you can skip this step. There is a next move that can make your life a lot easier. Our research team has already done the groundwork for you. All these stocks listed...
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.