FDA Requests Withdrawal Of Endo's Opana ER

The US regulatory agency has decided the long-acting opioid's benefits no long outweigh its risks, sparking concern that other strong steps on opioid abuse could be coming.

The US FDA’s request that Endo Pharmaceuticals Inc. remove Opana ER (oxymorphone extended-release) from the market due to safety issues could leave other opioid product marketers unsettled that they too could face the same fate.

On June 8, FDA announced it has asked Endo to remove the long-acting opioid because the drug’s reformulation in 2012...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

China Signals Restarting IPOs For Unprofitable Biotechs

 

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

More from Scrip

Syncona Looks To Go Private As Market Decline Deepens

 

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

ASCO: Pushing The Frontiers Of ADCs

 

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.