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Endo swings to Q2 loss on $775m pelvic mesh set-aside
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants. The generic drugmaker faced other setbacks this quarter, including the FDA asking that Endo pull its painkiller, Opana ER, from the market. The regulatory watchdog said that the benefits of the abuse-deterrent drug no longer outweigh the risks. Get the full story at our sister site, Drug Delivery Business News. The post Endo swings to Q2 loss on $775m pelvic mesh set-aside appeared...
Source: Mass Device - August 8, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Implants Legal News MassDevice Earnings Roundup Pain Management Pharmaceuticals Wall Street Beat Endo Pharmaceuticals Source Type: news

Impax Announces Settlement of Contract Litigation on Opana(R) ER (Oxymorphone Hydrochloride) CII Extended-Release Tablets
HAYWARD, Calif., Aug. 7, 2017 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (NASDAQ: IPXL), today announced a Settlement Agreement (the "Contract Settlement Agreement") to resolve a contract dispute relating to an agreeme... Biopharmaceuticals, Litigation Impax Laboratories, Opana ER, Oxymorphone, Endo International, Penwest (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 7, 2017 Category: Pharmaceuticals Source Type: news

Painkiller pulled from the market at FDA request
Opana ER's maker claims the opioid is safe if used as intended, but health officials say it carries multiple risks and is widely abused (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - July 7, 2017 Category: Consumer Health News Source Type: news

Opioid Opana ER to be pulled by pharmaceutical company
One month after the FDA asked it to remove an opioid from the market, pharmaceutical maker Endo has announced it will pull the drug. (Source: CNN.com - Health)
Source: CNN.com - Health - July 7, 2017 Category: Consumer Health News Source Type: news

Endo pulls opioid as U.S. seeks to tackle abuse epidemic
(Reuters) - Endo International Plc said on Thursday it agreed to withdraw its long-acting opioid painkiller Opana ER from the market after the U.S. Food and Drug Administration declared its benefit did not outweigh public health risks associated with opioid abuse. (Source: Reuters: Health)
Source: Reuters: Health - July 6, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Painkiller maker stops sales at FDA request because of abuse
Maker of painkiller Opana ER pulling drug off the market at FDA request because of abuse (Source: ABC News: Health)
Source: ABC News: Health - July 6, 2017 Category: Consumer Health News Tags: Health Source Type: news

Endo Pharma Agrees to Pull Abuse-Deterrent Opioid Endo Pharma Agrees to Pull Abuse-Deterrent Opioid
Following a June request by the FDA, the company will pull its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the market.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 6, 2017 Category: Consumer Health News Tags: Psychiatry News Alert Source Type: news

Endo agrees to pull opioid medicine from the market
Endo International said Thursday it will comply with a request by the Food and Drug Administration to voluntarily pull Opana ER from the market. In a statement, the company said it “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER, when used as intended." Endo also noted it has taken “significant steps” over the years to combat misuse and abuse of its opioid-based products. “Nevertheless , after careful consideration and consultation with the FDA… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 6, 2017 Category: Pharmaceuticals Authors: John George Source Type: news

Endo pulls painkiller from the market following FDA request
Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. To write off the remaining net book value of the product, Endo said it expects to incur a pre-tax impairment charge of $20 million in the 2nd quarter of this year. Opana brought in $158.9 million in net sales in 2016. Get the full story at our sister site, Drug Delivery Business News. The post Endo pulls painkiller from the ...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Endo Pharmaceuticals Source Type: news

Endo, Bowing to FDA, Pulls Opana ER From Market
(MedPage Today) -- Agency had requested that opioid product be withdrawn (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - July 6, 2017 Category: Primary Care Source Type: news

Endo to voluntarily remove opioid painkiller in U.S.
(Reuters) - Endo International Plc said it would voluntarily remove its long-acting opioid painkiller, Opana ER, a month after the U.S. Food and Drug Administration's (FDA) withdrawal request amid the growing opioid abuse crisis in the United States. (Source: Reuters: Health)
Source: Reuters: Health - July 6, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Endo Provides Update On Opana ER
DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 6, 2017 Category: Pharmaceuticals Source Type: news

FDA Calls for Opana ER's Removal Due to Abuse Concerns
On June 8, the FDA asked Endo Pharmaceuticals to pull its opioid pain medication, reformulated Opana ER, from the U.S. market because of concerns about abuse. (Source: AAFP News)
Source: AAFP News - June 12, 2017 Category: Primary Care Source Type: news

FDA Asks Opana ER Maker to Pull Drug from Market (FREE)
By Amy Orciari Herman Edited by Susan Sadoughi, MD, and Andr é Sofair, MD, MPH The FDA has asked the maker of Opana ER — an extended-release version of oxymorphone — to remove the drug from the market because " the benefits of the drug may no longer outweigh its risks. " In … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - June 12, 2017 Category: Primary Care Source Type: news

D.C. Week: Price Defends Budget Cuts for His Agency
(MedPage Today) -- Also: FDA declares war on Opana ER; conservative scholars blame culture for opioid mess (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - June 10, 2017 Category: Geriatrics Source Type: news

Mother sees hope amid opioid crisis
Five years ago, Emily Walden had never heard of the powerful prescription opioid Opana ER. Today, she is one of its biggest critics, and she sees the Food and Drug Administration's request this week that drugmaker Endo Pharmaceuticals pull the painkiller off the market as a sign of hope. (Source: CNN.com - Health)
Source: CNN.com - Health - June 9, 2017 Category: Consumer Health News Source Type: news

New FDA boss sends message on addictive opioids. Will this East Bay drug maker benefit?
In an apparent first step toward taking on the nation's opioid abuse epidemic, the Food and Drug Administration is asking Endo Pharmaceuticals to remove the opioid pain medication Opana ER from the market. If Endo complies with the FDA's Thursday request, it could be a boon for Impax Laboratories Inc., the Hayward manufacturer of a generic form of Opana ER before the drug was reformulated by Endo. “We are facing an opioid epidemic – a public health crisis — and we must take all necessary… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 9, 2017 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

New FDA boss sends message on addictive opioids. Will this East Bay drug maker benefit?
In an apparent first step toward taking on the nation's opioid abuse epidemic, the Food and Drug Administration is asking Endo Pharmaceuticals to remove the opioid pain medication Opana ER from the market. If Endo complies with the FDA's Thursday request, it could be a boon for Impax Laboratories Inc., the Hayward manufacturer of a generic form of Opana ER before the drug was reformulated by Endo. “We are facing an opioid epidemic – a public health crisis — and we must take all necessary… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 9, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

A Look Back: Abandoned Painkiller Makes a Comeback
(MedPage Today) -- Backstory on Opana ER, which the FDA now wants off the market (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 9, 2017 Category: American Health Source Type: news

FDA asks drugmaker to stop selling opioid painkiller Opana ER
U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it. (Source: CBC | Health)
Source: CBC | Health - June 9, 2017 Category: Consumer Health News Tags: News/Health Source Type: news

FDA wants opioid painkiller removed from market
The U.S. Food and Drug Administration, or FDA, Thursday requested Endo Pharmaceuticals remove its opioid pain medication Opana from the market due to risks. (Source: Health News - UPI.com)
Source: Health News - UPI.com - June 9, 2017 Category: Consumer Health News Source Type: news

FDA asks Endo to pull Opana from the market over concerns of abuse
The FDA asked Endo Pharmaceuticals (NSDQ:ENDP) to pull its opioid pain med, Opana ER, from the market, saying that the benefits of the abuse-deterrent drug no longer outweigh the risks. The move marks the 1st time the federal regulatory watchdog has urged a company to remove an opioid painkiller due to concerns of abuse. Get the full story at our sister site, Drug Delivery Business News. The post FDA asks Endo to pull Opana from the market over concerns of abuse appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 9, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Endo Pharmaceuticals Source Type: news

FDA Asks Maker of Opioid Painkiller Opana ER to Pull Drug from Market
Agency says the powerful medication's risk for abuse now outweighs any benefit Source: HealthDay Related MedlinePlus Pages: Medicines, Opioid Abuse and Addiction, Pain Relievers (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - June 9, 2017 Category: Consumer Health News Source Type: news

In a first, FDA asks drugmaker to yank an opioid from the market
FDA eyed role of Endo Pharmaceuticals' drug Opana ER in opioid epidemic (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 9, 2017 Category: Consumer Health News Source Type: news

FDA Asks Maker of Opioid Painkiller Opana ER to Pull Drug From Market
FRIDAY, June 9, 2017 -- Sales of reformulated Opana ER, a prescription opioid painkiller, should be halted in the United States, the U.S. Food and Drug Administration says. In its request Thursday for Endo Pharmaceuticals to voluntarily withdraw... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - June 9, 2017 Category: General Medicine Source Type: news

FDA Requests Removal of Opana ER From Market
FDA Requests Removal of Opana ER for Risks Related to Abuse (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - June 9, 2017 Category: General Medicine Source Type: news

F.D.A. Asks Drug Maker to Stop Selling a Dangerous Opioid
The agency ’ s request about the drug, Opana ER, may signal a more aggressive approach against prescription opioids that are found to be widely abused. (Source: NYT Health)
Source: NYT Health - June 8, 2017 Category: Consumer Health News Authors: DENISE GRADY Tags: Drugs (Pharmaceuticals) Food and Drug Administration Endo Pharmaceuticals Holdings Inc Pain-Relieving Drugs Source Type: news

FDA orders drugmaker to stop selling opioid painkiller
Endo Pharmaceuticals received an FDA warning on Thursday to remove Opana ER from the market. It is the first time US regulators have asked for a firm to discontinue an opioid painkiller. (Source: the Mail online | Health)
Source: the Mail online | Health - June 8, 2017 Category: Consumer Health News Source Type: news

U.S. asks drug maker Endo to withdraw opioid amid abuse crisis
WASHINGTON (Reuters) - As the United States battles a growing opioid abuse crisis, the Food and Drug Administration on Thursday asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller, Opana ER, sending Endo's shares down more than 12 percent. (Source: Reuters: Health)
Source: Reuters: Health - June 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA wants painkiller Opana ER pulled off market
The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse." (Source: CNN.com - Health)
Source: CNN.com - Health - June 8, 2017 Category: Consumer Health News Source Type: news

' Wow.' In A First, FDA Requests An Opioid Be Pulled From The Market
In a dramatic first, the Food and Drug Administration is requesting that Endo Pharmaceuticals remove the opioid Opana ER from the market because of its potential for causing abuse. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 8, 2017 Category: Pharmaceuticals Authors: Matthew Herper, Forbes Staff Source Type: news

FDA Asks Endo Pharma to Take Opana ER Off the Market FDA Asks Endo Pharma to Take Opana ER Off the Market
For the first time, the FDA has asked a company to remove a currently marketed opioid pain medication from the market because of the public health consequences of abuse.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 8, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA Wants Opana ER Off the Market
(MedPage Today) -- Marks first time agency has sought to pull an opioid due to abuse potential (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - June 8, 2017 Category: Psychiatry Source Type: news

FDA asks Endo to withdraw Opana ER opioid; shares fall
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down more than 12 percent. (Source: Reuters: Health)
Source: Reuters: Health - June 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Requests Removal of Opana ER for Risks Related to Abuse
June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 8, 2017 Category: Pharmaceuticals Source Type: news

Endo shares plummet as FDA requests removal of pain drug Opana ER
(Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - June 8, 2017 Category: Pharmaceuticals Source Type: news

FDA asks Endo to withdraw Opana ER opioid, shares fall
(Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down as much as 13 percent. (Source: Reuters: Health)
Source: Reuters: Health - June 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA requests removal of Opana ER for risks related to abuse
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 8, 2017 Category: American Health Source Type: news

FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market
The U.S. Food and Drug Administration (FDA) is calling on Endo Pharmaceuticals to stop selling a specific opioid painkiller, Opana ER, due to the "public health consequences of abuse." This is the first time the FDA has acted to remove an opioid from the market, citing the frequent misuse of the drug and associated outbreaks of HIV, hepatitis C, and another serious but less well-known blood disorder called thrombotic microangiopathy. Endo Pharmaceuticals released a statement highlighting their efforts to prevent abuse of the drug and stating that they are reviewing the FDA's request. (Source: News stories via the...
Source: News stories via the Rural Assistance Center - June 8, 2017 Category: Rural Health Source Type: news

FDA Panels Say Risks of Opana ER Outweigh Benefits FDA Panels Say Risks of Opana ER Outweigh Benefits
Members of the FDA's Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees conclude the abuse-deterrent oxymorphone's risks now outweigh its benefits.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - March 17, 2017 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

FDA Advisers: Opana's Benefits Don't Outweigh Its Risks (FREE)
By Amy Orciari Herman Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM The benefits of the opioid painkiller Opana ER — an extended-release version of oxymorphone — do not … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 15, 2017 Category: Primary Care Source Type: news

FDA panel: Endo opioid painkiller's risks outweigh its benefits
A Food and Drug Administration panel found, in an 18-8 vote, that the benefits of a newer formulation of Endo International ’s Opana ER — an extended-release, opioid pain medicine — no longer outweigh its risks. The FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees is reviewing oxymorphone products such as Opana ER because of the high abuse rate of such medicines. The FDA will make the final decision on whether to take any regulatory action… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - March 15, 2017 Category: Health Management Authors: John George Source Type: news

FDA Panel: Painkiller Opana ER Benefits No Longer Outweigh Risks
The benefits of an opioid painkiller linked to a 2015 HIV outbreak in Indiana no longer outweigh the risks, a panel of advisers to the U.S. Food and Drug Administration concluded Tuesday. (Source: WSJ.com: Health)
Source: WSJ.com: Health - March 15, 2017 Category: Pharmaceuticals Tags: PAID Source Type: news

FDA Joint Panel Votes Down Opana ER
(MedPage Today) -- Too many risks with reformulated version tied to HIV, TTP clusters (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - March 15, 2017 Category: Psychiatry Source Type: news

Opana ER (Oxymorphone Hydrochloride Extended Release) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 24, 2016 Category: Drugs & Pharmacology Source Type: news

Endo Announces U.S. District Court Ruling Upholding OPANA(R) ER Intellectual Property
DUBLIN, May 2, 2016 -- (Healthcare Sales & Marketing Network) -- Endo International plc (ENDP) (ENL.TO) today announced that the U.S. District Court for the Southern District of New York has issued an order upholding its August 2015 ruling in Endo's favor... Biopharmaceuticals, Generics, LitigationEndo International, OPANA (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 2, 2016 Category: Pharmaceuticals Source Type: news

Court upholds Endo patent ruling
The U.S. District Court for the Southern District of New York has issued an order upholding its August 2015 ruling in Endo’s favor and confirming the court’s prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana. Opana ER is an extended-release narcotic pain reliever used to treat moderate to severe pain. Actavis, the U.S. generics business of Allergan (NYSE: AGN), is marketing a non-crush-resistant generic version of Opana ER. Roxane Laboratories… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - May 2, 2016 Category: Pharmaceuticals Authors: John George Source Type: news

Drug Needle Exchanges Gain Ground After Indiana HIV OutbreakDrug Needle Exchanges Gain Ground After Indiana HIV Outbreak
Since Indiana opened its first state-run needle exchange last spring, Tara Burton, 25, has made weekly visits to turn over needles she used to shoot Opana, a prescription painkiller, up her track-marked arm. Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - August 7, 2015 Category: Infectious Diseases Tags: Infectious Diseases News Source Type: news

Injecting Opana Tied to Blood Clotting Disorder (CME/CE)
(MedPage Today) -- Are most clinicians aware of this side effect of oxymorphone drug abuse? (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - May 10, 2015 Category: Consumer Health News Source Type: news

Injecting Opioid Tied to Blood Clotting Disorder (CME/CE)
(MedPage Today) -- Are most clinicians aware of this side effect of oxymorphone drug abuse? (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - May 10, 2015 Category: Psychiatry Source Type: news