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generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.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

Editors Pick
Internet video service Sling TV, on Wednesday said HBO would be available in time for the "Game of Thrones" and "Silicon Valley" season premieres on April 12, but did not specify a launch date. Memory chip maker Micron Technology, Inc. said Wednesday after the markets closed that its second quarter profit rose 28% from last year, helped by higher sales and lower income tax expenses. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly sales. Apple Watch is expected to post robust sales in the first weekend after its launch on April 24. A craze for Apple Watch may catapult the smartwatch industry into a lucrative market, while a not-so-impressive response for the Apple device may weigh on the industry.
comments powered by Disqus
RELATED NEWS
Trade ACT now with 
Follow RTT