logo
Plus   Neg
Share
Email
Comment

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the generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.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
Cannae Holdings, Inc. said Wednesday that its portfolio company, Ceridian HCM Holding Inc., has confidentially filed for an initial public offering. Ceridian HCM, a provider of human resources software and services, filed a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission relating to the proposed IPO of its common stock. Goldman Sachs Group Inc. on Wednesday reported a loss for the fourth quarter, reflecting lower trading revenue in fixed income, currencies and commodities as well as a charge related to the recent U.S. tax reform. However, both adjusted earnings per share and revenues for the quarter topped analysts' expectations. Bank of America Corp. (BAC) reported a profit for the fourth-quarter of 2017 that declined about 50 percent from last year, hurt by a charge of $2.9 billion or $0.27 per share, related to the Tax Cuts and Jobs Act.
comments powered by Disqus
Follow RTT