Tag:
Opana
Latest Headlines
Latest Headlines
FDA nixes Endo petition to protect Opana ER from generics
Endo Health Solutions lost its bid to thwart generic makers copying its high-powered painkiller Opana ER. The FDA decided Endo's tamper-resistant formula doesn't prevent drug abuse significantly better than earlier versions that weren't designed to deter abuse. That's a blow for Endo, which took in almost $300 million from the drug last year, or 10% of its total sales.
Report: Endo, in a world of hurt, may be looking for a savior
Endo Health Solutions' is feeling the generics pain this year as its key products face copycats and that may be enough to have sent it looking for a buyer.
Panel vote will add to FDA pain drug puzzle
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
Judge blocks Endo's effort to block generic pain meds
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
White House adds voice to debate over generic painkillers
Here's another wrinkle in the debate over generic painkillers. Less than a week after Endo Health Solutions ($ENDP) sued the FDA to block cheap copies of non-tamper-resistant versions of its Opana pill, the White House is warning police and border officials to watch out for generic versions soon to be available in Canada.
New bill aims to mandate abuse-deterrent painkillers
On the heels of new addiction-fighting measures from FDA, Congressional reps are introducing a bill that would put the onus on drugmakers to curb abuse. The measure would require pain drugs to be formulated to deter abuse.
