Despite the advisory committee vote in March, Endo said that more than half the panel members "expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse".
The withdrawal marks the first time the agency taken steps to remove an opioid pain medication due to the public health implications and comes amid an intense national debate about the abuse of opioids. The agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA's request.
This marks the first time the FDA has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of opioid abuse.
If Opana ER sounds familiar, it's because it was the drug of choice for many addicts at the center of an HIV outbreak in IN in 2015.
"If Endo resists taking this off the market immediately, the people who are injured or killed as a result of it being on the market longer than it should, there will be a wave of product liability litigation against the company", said Sidney Wolfe, founder and senior adviser to consumer watchdog Public Citizen. "This is the first time the agency has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of abuse".
About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin. In 2012, Endo replaced the original formulation of Opana ER with a new formulation meant to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
Trump, EPA chief meet ahead of decision on climate change
UN Secretary-General Antonio Guterres has said it was "absolutely essential" that the Paris climate agreement be implemented. In announcing his decision, Trump said he was "elected to represent the citizens of Pittsburgh, not Paris".
The request was made after the FDA determined that injecting the drug, which is one way of abusing it, was linked to outbreaks of disease, including HIV and hepatitis C.
If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed. Some other states and cities have filed similar lawsuits.
"We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse", said FDA commissioner Scott Gottlieb.
Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".
Endo's shares fell 12.2 percent to US$12.10 in extended trading.
Opana ER brought in $158 million in sales past year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.
McCullers was removed after seven innings, permitting one run and two hits, while striking out eight and walking two. But things changed as with the injuries to Charlie Morton and Joe Musgrove certainly tested the wits of our bullpen.
He's been the Predators' starting goalie since the 2008-09 season and has now become their most valuable playoff performer. Gill has been a season ticket holder since the inaugural season of 1998-99 and was on the committee to design the arena.
Having the extra port is vitally important when you're using an external device like a USB-C SSD and the charger simultaneously. The 12-inch MacBook is Apple's thinnest laptop , measuring 0.52 by 11.04 by 7.74 inches (HWD), and weighing 2.03 pounds.
Executive privilege is a legal loophole that allows the president to withhold information from other government branches. Trump also said in an interview that he was thinking of "this Russian Federation thing" when he chose to fire Comey.
Three-time major victor Padraig Harrington has been forced to withdraw from this week's St Jude Classic due to a freak injury. He had already failed to qualify for next week's US Open and was able to see the amusing side.
Wawrinka's lone worrying moment resulted when he nearly turned an ankle near the net in the last game against Cilic. Friday's semi-final will be the fourth meeting between Nadal and Thiem this season, all of which have come on clay.
England is the bookies' favorite for the trophy, but Bangladesh has beaten England at the last two Cricket World Cups. India's pacers helped India maintain the pressure as they reduced 22/6 after just eight overs.
He was released on his own recognizance at 10:50 a.m. and is scheduled to be arraigned on July 5 at Palm Beach County court. Both tires on the left side of the auto were flat, and police described fresh damage to the driver's side.
She said a white transit van had knocked several pedestrians over, estimating five or six casualties injured or seriously injured. One witness, Mark Roberts, told CNN he was on the bridge when a van came swerving down the roadway at a high rate of speed.
Powerball jackpot jumps to $435 million
Telecast live from the Florida Lottery Studios in Tallahassee , the Powerball drawing was for a whopping $380.6 million. You do not need to have the same order as the numbers on the ticket, though the Powerball number is not interchangeable.
House panel issues subpoenas for Flynn, others
The committee has ordered lawyer Michael Cohen and security adviser Michael Flynn to appear before them and supply documents. There is disagreement about whether those three subpoenas were issued without the knowledge of committee Democrats.
New smart speaker expected as Apple kicks off conference
HomePod will go on sale in December in Australia, the U.S. and the United Kingdom and will cost American consumers $349 (A$465). You can activate it with a wake word - "Hey Siri" - and ask an artificially intelligent assistant, Siri, to play music.
Apple unveils HomePod speaker at WWDC 2017
Later Monday, it's expected to announce an internet-connected smart speaker to compete with Amazon's Echo and Google's Home . The research firm IDC says Apple and Xiaomi each has a worldwide market share of almost 15 percent in the first quarter.
Yankees smash Blue Jays in record-tying fashion
The Blue Jays tacked on two more runs against Pineda with a third inning sacrifice fly and fourth inning wild pitch. The young closer boasts a 2.78 ERA, 0.84 WHIP, and 29/2 K/BB ratio in 22 2/3 innings this season for the Jays.