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Opana ER

Type: Product

Name: Opana ER

First reported May 20 2013 - Updated May 20 2013 - 1 reports

Pfizer Inc

FDA Painkiller Abuse Concerns Creating Opportunity For Pfizer

In case you haven't heard, pain medication abuse is getting pretty bad. In the U.S., deaths from prescription painkillers are outpacing those from heroin and cocaine combined. The FDA has noticed and is inadvertently creating new opportunities for pharmaceutical ... [Published Seeking Alpha - May 20 2013]

Entities: FDA Food & Drug Administration, Pfizer Inc, Embeda, Abuse, anodyne

First reported May 15 2013 - Updated May 15 2013 - 1 reports

FDA Food & Drug Administration

FDA allows continued sale of generic Opana painkiller

The agency determined that a newer version of the drug was not better at deterring abuseThe Food and Drug Administration (FDA) announced Friday that it will allow the continued sale of generic forms of the prescription pain drug Opana ER, after the agency ... [Published Inside Counsel - May 15 2013]

Entities: FDA Food & Drug Administration, Opana ER, anodyne

First reported May 13 2013 - Updated May 14 2013 - 9 reports

Endo hit hard by FDA's refusal to reject generics

Endo's stock fell 5 percent Friday, then 3.6 percent more Monday, closing at $33.71.vern-based Endo Health Solutions Inc. dealt Monday with the fallout from an adverse decision Friday by the Food and Drug Administration, which rejected Endo's complicated ... [Published Philly.com - May 14 2013]

Entities: FDA Food & Drug Administration, Opana ER, opioid, anodyne

First reported May 14 2013 - Updated May 14 2013 - 1 reports

FDA Decision Opens Way to Generics of Original Opana ER

Following a decision to block new generic versions of non-abuse-deterrent oxycodone, the FDA today denied a petition from Endo Pharmaceuticals, opening the way for new generic versions of oxymorphone.Medscape Medical News ... [Published WebMD - May 14 2013]

Entities: Opana ER, Endo Pharmaceuticals Holdings Incorporated, Medscape

First reported May 13 2013 - Updated May 13 2013 - 1 reports

Qihoo 360 Technology Co Ltd

Stocks Weaken In Late Trade; Qihoo, YY Slide

Posted 03:07 PM ETStocks were again mixed in late trading Monday, but conditions have weakened.The Nasdaq was up 0.1%, while the S&P 500 ticked up a fraction. Earlier, the Nasdaq touched a fresh 12-year high and the S&P 500 briefly hit a record high. ... [Published Investors Business Daily - May 13 2013]

Entities: Qihoo 360 Technology Co Ltd, Copa Holdings SA, S&P 500, WuXi PharmaTech Cayman Inc, Opana ER

First reported May 10 2013 - Updated May 11 2013 - 19 reports

Generic version of narcotic Opana still for sale despite concerns

Federal regulators said Friday they would continue to allow sales of generic Opana, a narcotic painkiller similar to OxyContin, even though the pills are prone to abuse.Like OxyContin, Opana is an extended-release narcotic designed to offer pain relief ... [Published Individual.com - May 11 2013]

Entities: Generic Version, Narcotic, OxyContin

First reported May 10 2013 - Updated May 10 2013 - 1 reports

BRIEF-Endo Health down 2.8 percent in extended trade

Endo Health Solutions Inc :* Down 2.8 percent to $34 in extended trade after FDA decisionon generic versions of Endo's Opana ER ... [Published Reuters - May 10 2013]

Entities: Opana ER, Endo Health Solutions Inc

First reported May 08 2013 - Updated May 09 2013 - 1 reports

Depomed Reports First Quarter 2013 Financial Results

/PRNewswire/ -- Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the quarter ended March 31, 2013.First Quarter 2013 Update-- Total revenues of $26.2 million, an increase of 55% over first quarter 2012 -- Gralise(®) (gabapentin) net sales ... [Published NewsBlaze - May 08 2013]

Entities: Depomed Inc, Zipsor, Gralise

First reported May 07 2013 - Updated May 07 2013 - 2 reports

Endo Health Solutions Management Discusses Q1 2013 Results - Earnings Call Transcript

8:30 AM ETOperatorGood day, ladies and gentlemen, and welcome to the Q1 2013 Endo Health Solutions Inc. Earnings Conference Call. My name is Gary, and I will be your coordinator for today. [Operator Instructions] As a reminder, this call is being recorded ... [Published Seeking Alpha - May 07 2013]

Entities: Opana ER, Endo Health Solutions Inc, Lidoderm

First reported May 07 2013 - Updated May 07 2013 - 2 reports

Endo Health turns 1Q profit, affirms 2013 forecast

MALVERN, Pa. -- Endo Health Solutions Inc. turned a first-quarter profit, reversing a lost at the start of 2012, when the drug developer absorbed a sizeable pre-tax charge tied to a settlement and license agreement.The Malvern, Pa., company said Tuesday ... [Published Equities.com - May 07 2013]

Entities: Opana ER, Lidoderm, Drugs, Endo Health Solutions Inc

First reported May 07 2013 - Updated May 07 2013 - 4 reports

Endo Reports First Quarter Financial Results

/PRNewswire/ -- (Nasdaq: ENDP) today reported first quarter 2013 total revenues of $709 million, compared to $691 million for the same quarter of 2012. Endo reported first quarter 2013 net income of $15 million, compared to a reported net loss of $87 ... [Published Freshnews.com - May 07 2013]

Entities: Endo Pharmaceuticals Holdings Incorporated, Opana ER, Lidoderm

First reported Apr 30 2013 - Updated Apr 30 2013 - 1 reports

D.C.-based doctor indicted on federal drug charges in SW Va.

ABINGDON A Washington, D.C.-based doctor who allegedly prescribed thousands of painkillers to patients in Southwest Virginia was indicted on multiple felony counts recently by a federal grand jury in Abingdon.The 36-count indictment against Alen Johannes ... [Published Kingsport Times-News - Apr 30 2013]

Entities: Alen J. Salerian, Indictment, Abingdon (Virginia, United States), Drug Charge

Quotes

According to the FDA's statement regarding the original Opana ER relisting, the FDA "continues to encourage the development of abuse-deterrent formulations of opioids to help reduce prescription drugdrug abuse." Endo's petition was shot down because the regulator concluded the new abuse resistant version wasn't actually crush-proof or syringe-proof

FDA Painkiller Abuse Concerns Creating Opportunity For Pfizer [Published Seeking Alpha - May 20 2013]

"Reformulated Opana ER can be readily prepared for injection, despite Endo's claim," the FDA said in a statement. "It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods."

FDA allows continued sale of generic Opana painkiller [Published Inside Counsel - May 15 2013]

"Based on these 2 recent decisions, we sense that FDA is setting a standard for how much effectiveness is required from the various tamper-proof mechanisms in order to delay the launch of generic alternatives,” Cynthia Ambres, MD, partner, US member of KPMG’s Global Healthcare Center of Excellence, told Formulary."

FDA denies request to block generic versions of Opana ER [Published Formulary Journal - May 15 2013]

Endo said Friday that the FDA decision might mean $120 million less in revenue for the rest of 2013 and that the company was "actively pursuing cost-reduction actions that will reduce the earnings effect of FDA's decision."

Endo hit hard by FDA's refusal to reject generics [Published Philly.com - May 14 2013]

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FDA allows continued sale of generic Opana pain... [Published Inside Counsel - May 15 2013]
FDA denies request to block generic versions of... [Published Formulary Journal - May 15 2013]
Endo’s petition to block generic forms of Opana... [Published Drugtopics.com - May 14 2013]
Endo hit hard by FDA's refusal to reject generics [Published Philly.com - May 14 2013]
FDA Decision Opens Way to Generics of Original ... [Published WebMD - May 14 2013]
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Setback for Endo Health on Opana ER Zacks [Published Yahoo! Finance - May 13 2013]
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What Companies Will This FDA Decision Impact? [Published Wall St. Cheat Sheet - May 13 2013]
US EQUITIES OPENING HEADLINES INCLUDING: US equ... [Published Proactiveinvestors United Kingdom RSS feed - May 13 2013]
FDA Determines Original OPANA ER Not Discontinu... [Published FDA Law Blog - May 13 2013]
Generic version of narcotic Opana still for sal... [Published Individual.com - May 11 2013]
FDA Rules to Continue Sales of Generic Opana Pa... [Published French Tribune - May 11 2013]
Rogers Disappointed by FDA Painkiller Decision [Published Congressman Hal Rogers - May 11 2013]
FDA allows sales of generic Opana painkiller to... [Published Los Angeles Times - May 11 2013]
FDA Rejects Endo’s Petition to Deny Generics o... [Published FDA News - May 11 2013]
F.D.A. Rejects Request to Block Sales of Generi... [Published New York Times - May 11 2013]
FDA Allows Generic Form of Powerful Painkiller ... [Published BioPortfolio - May 11 2013]
FDA rejects Endo's citizen petition on opioid p... [Published Philly.com - May 11 2013]

Blogs

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Analysts: Cisco Valuation is Positive and 3 Oth... [Published Wall St. Cheat Sheet - May 13 2013] Cisco Systems ( NASDAQ:CSCO ): FBR Capital, citing valuation and better than expected SDN overlay solutions traction, has brought Cisco from Underperform to Market Perform, and raised the price target from $17 $19.NEW! Discover a new stock idea each ...
Analysts: Cisco Valuation is Positive and 3 Oth... [Published Wall St. Cheat Sheet - May 13 2013] Cisco Systems ( NASDAQ:CSCO ): FBR Capital, citing valuation and better than expected SDN overlay solutions traction, has brought Cisco from Underperform to Market Perform, and raised the price target from $17 $19. NEW! Discover a new stock idea ...
What Companies Will This FDA Decision Impact? [Published Wall St. Cheat Sheet - May 13 2013] The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The Wall ...
What Companies Will This FDA Decision Impact? [Published Wall St. Cheat Sheet - May 13 2013] The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The ...
FDA Determines Original OPANA ER Not Discontinu... [Published FDA Law Blog - May 13 2013] By Kurt R. Karst –Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) ...

Press Releases

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Endo Health Solutions Responds to FDA's Denial ... [Published Financial Services - May 10 2013]
Watson Confirms Opana® ER Patent Challenge [Published PR Newswire: Policy & Public Interest - Jan 23 2013]
Endo Health Solutions Launches 7.5mg and 15mg s... [Published PR Newswire: Health - Dec 11 2012]
Endo Health Solutions Sues FDA to Protect Consu... [Published PR Newswire - Nov 30 2012]
Endo Health Solutions Announces Receipt of Para... [Published PR Newswire - Sep 26 2012]