| MedlinePlus Health News Posted: 10 Sep 2013 08:34 AM PDT
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| CDER New September 10, 2013 Posted: 10 Sep 2013 07:00 AM PDT 
What's New on the FDA Drugs Site September 9, 2013
New and Generic Drug Approvals September 6, 2013 | Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type | | Abraxane | paclitaxel | For Suspension; Iv (Infusion) | Abraxis Bioscience | New or Modified Indication | | Adrenaclick | epinephrine | Injectable; Im-Sc | Amedra Pharms | Manufacturing Change or Addition | | Apidra | insulin glulisine recombinant | Injectable; Iv (Infusion)-Sc | Sanofi Aventis Us | Labeling Revision | | Apidra Solostar | insulin glulisine recombinant | Injectable; Subcutaneous | Sanofi Aventis Us | Labeling Revision | | Aricept | donepezil hydrochloride | Tablet; Oral | Eisai Inc | Labeling Revision | | Aricept | donepezil hydrochloride | Tablet; Oral | Eisai Inc | Labeling Revision | | Aricept Odt | donepezil hydrochloride | Tablet, Orally Disintegrating; Oral | Eisai Inc | Labeling Revision | | Dilantin-125 | phenytoin | Suspension; Oral | Parke Davis | Manufacturing Change or Addition | | Dilantin-30 | phenytoin | Suspension; Oral | Parke Davis | Manufacturing Change or Addition | | Humalog | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition | | Humalog Kwikpen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition | | Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition | | Lovenox | enoxaparin sodium | Injectable; Intravenous, Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition | | Lovenox (Preservative Free) | enoxaparin sodium | Injectable; Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition | | Macrobid | nitrofurantoin; nitrofurantoin, macrocrystalline | Capsule; Oral | Alvogen Inc | Labeling Revision | | Macrodantin | nitrofurantoin, macrocrystalline | Capsule; Oral | Alvogen Inc | Labeling Revision | | Magnevist | gadopentetate dimeglumine | Injectable; Injection | Bayer Hlthcare | Manufacturing Change or Addition | | Nascobal | cyanocobalamin | Spray, Metered; Nasal | Par Pharm | Manufacturing Change or Addition | | Potiga | ezogabine | Tablet; Oral | Glaxosmithkline | Labeling Revision | | Prilosec Otc | omeprazole magnesium | Tablet, Delayed Release; Oral | Astrazeneca | Labeling Revision | | Twinject 0.15 | epinephrine | Injectable; Im-Sc | Amedra Pharms | Manufacturing Change or Addition | | Twinject 0.3 | epinephrine | Injectable; Im-Sc | Amedra Pharms | Manufacturing Change or Addition | | Zosyn | piperacillin sodium; tazobactam sodium | Injectable; Injection | Wyeth Pharms Inc | Labeling Revision | | Zosyn In Plastic Container | piperacillin sodium; tazobactam sodium | Injectable; Injection | Wyeth Pharms Inc | Labeling Revision |
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| Hyscience Posted: 10 Sep 2013 05:11 AM PDT
| Food Stamp Usage Update Posted: 09 Sep 2013 03:52 PM PDT No surprise, the Obama economy continues with ... you guessed it ... another record-breaking month for food stamps: The number of households on food stamps reached another record high in June, according to recently released data from the Agriculture Department. According to the USDA, 23,116,928 households participated in the Supplemental Nutrition Assistance Program, or food stamps in June, up from 23,071,020 the month prior and up from the previous record high of 23,115,206 in March. More here. Of course we can't blame it all on just the Obama economy itself. After all, it indeed has much to do with the Obama agenda of making Americans more and more dependent on big government, which makes for a bigger and bigger Democrat base.
| | BREAKING: George Zimmerman Arrested!! (Update - NO ARREST - Yet) Posted: 09 Sep 2013 01:09 PM PDT Update: Despite earlier reports, George Zimmerman was not arrested. The case supposedly involves Zimmerman, his estranged wife, and Zimmerman's father-in-law. According to Fox News, Zimmerman is in handcuffs in the back of a police cruiser while the cops try to sort out what happened. He could end up being arrested. 
Original post begins here: Clickorlando.com reported in the last few minutes that the Lake Mary police confirmed that they were called to an address on Sprucewood Road this afternoon, that George Zimmerman has been arrested, and that he is currently in police custody. Zimmerman's arrest today comes just one day after his wife Shellie filed for divorce. He apparently threatened his wife with a gun. Lake Mary police spokesman Zach Hudson said police are "trying to determine what exactly happened."
| | D.C. Denies Permit To Patriotic "2 Million Bikers To D.C." Rally To Protest Planned Million Muslim March On 9/11 ... Bikers Not Deterred - Ride Will Go On Anyway! Posted: 09 Sep 2013 12:51 PM PDT 
(Via BizPacReview) The countdown to Sept. 11 commemoration demonstrations by patriotic bikers versus a fringe Muslim "truther" group is taking shape, and despite some confusion about the technicalities, the court of popular opinion isn't even close: Denied a permit by the nation''s capital for a special "non-stop" ride through town with a waiver for red lights, stop signs and other traffic controls, organizers of the "2 Million Bikers to DC" ride to remember 9/11 are undeterred. Just riding on a public street doesn't take any special permission after all, even if you have a million people doing it. They just sought the permit to make life easier on the city's residents and businesses. So the ride will go on. It's just going to take a little longer. Keep reading, there's more ... As the piece goes on to note, meanwhile, the Muslims have a permit, but how much of a protest is tough to predict. The Muslim's demonstration has drawn little support from better known Muslim groups and will likely be dwarfed by the bikers in the streets.
| | Senior WH official on Syria strike: "Cry spoon and let slip the forks of war! Posted: 09 Sep 2013 12:24 PM PDT My first thought was that this had to be satire. But given what we've seen coming out of the Obama administration, that thought lasted only a nanosecond. Johah Goldberg writes: Here's the latest explanation of the White House's thinking: "A second senior official, who has seen the most recent planning, offered this metaphor to describe such a strike: If Assad is eating Cheerios, we're going to take away his spoon and give him a fork. Will that degrade his ability to eat Cheerios? Yes. Will it deter him? Maybe. But he'll still be able to eat Cheerios." I for one am ecstatic that our foreign policy establishment has confirmed the wisdom of The Tick:
"Cry spoon and let slip the forks of war!"
On the other hand, this has gotta be satire, right? Not even the Obama administration could be so inept ... yet, on the other hand ... it happens to be exactly what is being reported by USA Today. | | Judge Janine Pirro Shreds Obama for Benghazi and Syria (Must-see video) Posted: 09 Sep 2013 12:17 PM PDT You gotta check out this riveting 10 minute anti-Obama rant from Fox News' Judge Janine Pirro. Watch as she calls Obama out for refusing to approve a rescue operation that could have saved the lives of four Americans killed by Islamists in Beghazi one year ago this week, and takes Obama to task for asking the American people to trust his judgment.
Hat tip - LibertyNews | | Pew: Opposition to Syrian Airstrikes Surges Posted: 09 Sep 2013 11:08 AM PDT 
Pewreports that their new survey shows that over just the past week, the share of Americans who oppose U.S. airstrikes in Syria has surged 15 points, from 48% to 63%, as many who were undecided about the issue have turned against military action. By contrast, the share of Americans who support airstrikes remains virtually unchanged: Just 28% favor U.S. military airstrikes against Syria in response to reports that its government used chemical weapons. Also, a new CNN poll finds 71 percent of respondents oppose intervention if Congress doesn̢۪t pass an authorization for the use of military force, a measure at least the House currently looks unlikely to approve. Fifty-nine percent believe Congress shouldn̢۪t pass such a resolution, and 55 percent would still oppose airstrikes even if Congress did pass it. As we say in the South, needless to say President Obama has 'a hard row to hoe' to get support from Congress when their constituents are so rock-hard against it.
| | John Kerry: 'Unbelievably Small' Strike On Syria (Video) Posted: 09 Sep 2013 08:11 AM PDT While in London on Monday making the case for military action in Syria, Secretary of State John Kerry claimed that a strike on Syria would be "unbelievably small." As Patterico aptly notes, this is so absurd you have to check to make sure it's not satire. Assad has crossed Obama's "red line," we are told, and America's credibility is at stake. What better way to build our credibility than to promise an attack that is "unbelievably small"?
JOHN KERRY: I believe that the aftermath of the Iraq experience and Afghanistan left a lot of people saying, we don't want to see our young people coming back in a body bag and so forth. But that's not what we are talking about and what we have to do is make clear to people that this is were not talking about war. We are not going to war. We will not have people at risk in that way. We will be able to hold Bashar Assad accountable without engaging in troops on the ground or any other prolonged effort. In a very limited, very targeted, very short-term effort, that degrades his capacity to deliver chemical weapons without assuming responsibility for Syria's civil war. That is exactly what were talking about doing an unbelievably small, limited kind of effort. Now you know that has been engaged in previously on many different occasions. One can't help but wonder if the strike is to be "unbelievably small," then why bother at all ... that is other than to attempt to salvage the president's credibility, p*ss off Assad to commit more attrocities (assuming that it was his forces that in fact was the ones who did the chemical attacks), the Russians, and Iran, and make Obama, and the U.S. because of him, more of a laughing stock in the eyes of its jihadist enemies. Hat tip - Washington Beacon
| | What could possibly go wrong? Posted: 09 Sep 2013 07:58 AM PDT From the NYTimes - As Worries Over the Power Grid Rise, a Drill Will Simulate a Knockout Blow WASHINGTON -- The electric grid, as government and private experts describe it, is the glass jaw of American industry. If an adversary lands a knockout blow, they fear, it could black out vast areas of the continent for weeks; interrupt supplies of water, gasoline, diesel fuel and fresh food; shut down communications; and create disruptions of a scale that was only hinted at by Hurricane Sandy and the attacks of Sept. 11. This is why thousands of utility workers, business executives, National Guard officers, F.B.I. antiterrorism experts and officials from government agencies in the United States, Canada and Mexico are preparing for an emergency drill in November that will simulate physical attacks and cyberattacks that could take down large sections of the power grid. They will practice for a crisis unlike anything the real grid has ever seen, and more than 150 companies and organizations have signed up to participate. Read HERE. | | Shoulda stayed in bed McDonough Posted: 09 Sep 2013 07:03 AM PDT Media two, McDonough zip. I have a vision of this man walking a mile long hall of mirrors, posture erect, head held high looking neither to the left or right. The moment he passes each mirror, it shatters into a million pieces. And he proceeds without concern sure in his belief we are just stupid enough to believe the BS.
"The United states government does what it says, and we will do what we say in this instance, as we do in every other instance Chris, I have no doubt about that."
LOST! ONE PICCOLO! Please return to Pied Piper stat!
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| Everest Trek Posted: 10 Sep 2013 03:12 AM PDT
| Watch our weekly news bulletin, News of the Week (30 August -- 06 September) Posted: 10 Sep 2013 02:34 AM PDT <!-- Body_Start --> Can't view this? Click the URL or paste it into your browser: http://www.indiantelevision.com/advt/general/mailer/y2k13/sep/10sep-indiantelevision.com-mailer.htm This communication is brought to you by Indiantelevision.com If you do not wish to receive further  | | HT Breaking News: Sensex up by over 600 points Posted: 10 Sep 2013 02:17 AM PDT Hindustan Times Breaking News Sensex up by over 600 pointsDate: Sep 10 2013 2:36PMSensex up by over 600 pointsClick here if you do not wish to receive news alerts from Hindustan Times in future  | | HT Latest News: Delhi gang-rape verdict out, all four accused held guilty; sentencing tomorrow Posted: 10 Sep 2013 12:27 AM PDT Hindustan Times Latest News Delhi gang-rape verdict out, all four accused held guilty; sentencing tomorrowDate: Sep 10 2013 12:06PMA Delhi court today convicted all four accused in the gang-rape and death of a physiotherapy student in December last year--a crime that sparked nationwide protests and  | | HT Breaking News: All 4 accused convicted in Delhi gangrape case Posted: 10 Sep 2013 12:14 AM PDT Hindustan Times Breaking News All 4 accused convicted in Delhi gangrape caseDate: Sep 10 2013 12:35PMAll 4 accused convicted in Delhi gangrape caseClick here if you do not wish to receive news alerts from Hindustan Times in future  | | India's New News Leader Posted: 09 Sep 2013 11:30 PM PDT <!-- Body_Start --> Can't view this? Click the URL or paste it into your browser: http://www.indiantelevision.com/advt/general/mailer/y2k13/sep/10sep-newsX-mailer.htm This communication is brought to you by NewsX in association with Indiantelevision.com If you do not  | | HT Breaking News: Sensex 500 points up as Syria fears subsidise Posted: 09 Sep 2013 10:28 PM PDT Hindustan Times Breaking News Sensex 500 points up as Syria fears subsidiseDate: Sep 10 2013 10:48AMSensex 500 points up as Syria fears subsidiseClick here if you do not wish to receive news alerts from Hindustan Times in future  | | Mahabharat Redux on Star Plus, Life Ok's Bachelorette bet with Mallika, Balaji’s bright new sparks, HBO Asia to air first original series - Indiantelevision.com's The Ad Linx dated 10 September 2013 Posted: 09 Sep 2013 09:52 PM PDT <!-- Body_Start --> 10 Sep 2013 Newsletter Subscription Email this Page Volume 36 - Issue No: 26  | | Balaji sparks off new talent, Mahabharat Redux on Star Plus, Life Ok's Bachelorette bet with Mallika, HBO Asia to air first original series - Indiantelevision.com's The TV Linx dated 10 September 2013 Posted: 09 Sep 2013 09:46 PM PDT 10 Sep 2013 | Volume 39 - Issue No:64 | Visit Indiantelevision.com HBO Asia to air first original series Balaji Telefilms returns  | | See New Innovations, Make New Connections @ InfoComm India 2013-09-05 Posted: 09 Sep 2013 04:19 AM PDT <!-- Body_Start --> Can't view this? Click the URL or paste it into your browser: http://www.indiantelevision.com/advt/general/mailer/y2k13/sep/5sep-info-comm-india-mailer.htm 16-18  |  |
| General Mills Announces Voluntary Recall of Limited Quantity of Refrigerated Pillsbury Cinnamon Rolls With Icing Posted: 10 Sep 2013 01:46 AM PDT You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available. . For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
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| Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor Posted: 10 Sep 2013 01:46 AM PDT You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available. . For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
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| Nominations Now Being Accepted for NADCP Board of Directors Posted: 09 Sep 2013 02:03 PM PDT 
NADCP Seeks Dynamic Leaders to Serve on Board of Directors
Nominations for the 2014-15 Class Now Being Accepted NADCP is pleased to announce that we are now accepting nominations to serve on the 2014-2015 NADCP Board of Directors (beginning July 2014). The deadline to submit nominations is September 30, 2013. The NADCP Board of Directors Nomination and Orientation Committee is recruiting individuals with specific experience to fill up to three Board positions. A term on the Board, as elected by the NADCP membership, lasts two years with the possibility to serve up to two additional terms for a total of six years.
The NADCP Board of Directors (BOD) seeks to be diverse and currently represents a significant number of Treatment Court practitioners such as judges, prosecutors, defense attorneys, probation and law enforcement officers, clinicians, etc. The following areas are underrepresented on the BOD and are examples of the types of people the BOD is lacking. Preference will be given to individuals who are committed to the Treatment Court movement (e.g., Adult Drug Court, Juvenile Drug Court, Family Drug Court, Tribal Drug Court, Reentry Drug Court, DWI Court, Veterans Treatment Court, Mental Health Court, etc.) and who are nationally (and state) recognized, having influence as an elected prosecutor / attorney general; researcher in the field of addictions; former governor; and former member of Congress. Preference will also be given to members of national foundation boards as well as private sector business leaders.
To nominate an outstanding candidate to serve on the NADCP Board of Directors, please download the Nomination Form and Board of Directors Job Description.
Join the conversation and enjoy inspiring photos, news and stories on Drug Courts every day on our social media!   
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| FDA MedWatch - Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor Posted: 09 Sep 2013 01:27 PM PDT Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor AUDIENCE: Consumer, Pharmacy, Patient, Health Professional ISSUE: Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall. BACKGROUND: Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product label and corresponding medication name and lot number (see firm press release for lot numbers). RECOMMENDATION: Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and healthcare providers with questions regarding this recall can contact Avella at (877) 738-0797 Monday through Friday between 6am and 6pm Pacific Standard Time or via e-mail at QA@avella.com. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: - Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367719.htm
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| Inform:Smart sharing of informations Posted: 09 Sep 2013 01:23 PM PDT |
| Notice 2013-57 -- Affordable Care Act -- Health Savings Accounts Posted: 09 Sep 2013 12:12 PM PDT |
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