MedlinePlus Health News Posted: 12 Sep 2013 08:37 AM PDT U.S. National Library of Medicine · 8600 Rockville Pike · Bethesda, MD 20894 · 888-346-3656 |   |
CDER New September 12, 2013 Posted: 12 Sep 2013 08:13 AM PDT  What's New on the FDA Drugs Site September 11, 2013 New and Generic Drug Approvals September 10, 2013 Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type | Avodart | dutasteride | Capsule; Oral | Glaxosmithkline | Manufacturing Change or Addition | Children's Claritin | loratadine | Tablet, Chewable; Oral | Schering Plough | Manufacturing Change or Addition | Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5% In Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5% In Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5% In Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5% In Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 10meq | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 15meq (K) | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 20meq | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 20meq (K) | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 30meq | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 40meq | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 5meq | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.2% and Potassium Chloride 5meq (K) | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Fortesta | testosterone | Gel, Metered; Transdermal | Endo Pharms | Supplement | Lamisil | terbinafine hydrochloride | Cream; Topical | Novartis | Manufacturing Change or Addition | Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision | Prepidil | dinoprostone | Gel; Endocervical | Pharmacia and Upjohn | Manufacturing Change or Addition | Varenicline | varenicline | Tablet; Oral | Teva Pharms Usa | Tentative Approval | Xopenex Hfa | levalbuterol tartrate | Aerosol, Metered; Inhalation | Sunovion | Labeling Revision | Zolpidem Tartrate | zolpidem tartrate | Tablet, Extended Release; Oral | Apotex Inc | Approval | This email was sent to smart_z64.weblogs@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |   |
Congressional Pictorial Directory: A Great Memory Jogger Posted: 12 Sep 2013 08:07 AM PDT This email was sent to smart_z64.weblogs@blogger.com on behalf of: Government Printing Office (GPO) · 732 N Capitol Street, NW · Washington, DC 20401 · 866-512-1800 | 
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Hyscience Posted: 12 Sep 2013 05:10 AM PDT "How dead inside does he think we are?" Posted: 11 Sep 2013 11:14 PM PDT It was a question posed by Glenn Beck today. "They keep telling us that Islam is not our enemy, that it is Al-Qaida, then how are we aiding and abetting, how are we seriously being asked to aid and abet the enemy of the United States of America? How's that possible. And how is it possible, how dead inside does he think we are to ask us to go along with it on the eve of September 11th." The person who has forgotten 9/11, the person who is dead inside is Hussein Obama.
| Number of People Who Showed Up For "Million Muslim March" ... 21 Posted: 11 Sep 2013 07:20 PM PDT | AP: Colo. lawmakers ousted in gun control recalls Posted: 11 Sep 2013 11:53 AM PDT The Associated Press reported early this morning that the recall vote against two Democrat lawmakers who championed tougher gun laws in Colorado succeeded, . Senate President John Morse, along with Sen. Angela Giron were turned out by voters angered over their support for citizen disarmament measures so extreme that manufacturers are leaving the state and a "sporting sequester" boycott has been proposed. Republican Bernie Herpin, a former Colorado Springs city councilman, will replace Morse and former Deputy Police Chief George Rivera will take over from Giron, who represented Pueblo:
[...] Angered by new limits on ammunition magazines and expanded background checks, gun-rights activists tried to recall a total of four lawmakers but only succeeded in launching efforts against Morse and Giron. It was the first for state legislators since Colorado adopted the procedure in 1912. The recalls were seen as the latest chapter in the national debate over gun rights - and, for some, a warning to lawmakers in swing states who might contemplate gun restrictions in the future. But the vote also exposed divisions between the growing urban and suburban areas and more rural areas in a state where support for guns hasn't really been a partisan issue. Dozens of elected county sheriffs have sued to block the gun laws and some activists are promoting a largely symbolic measure to secede from the state. More here. This is just the beginning, but sooner or later the Democrats are going to get the message that the 2nd Amendment matters, it's there in the Constitution for a reason, and freedom-loving Americans aren't going to take the liberal-progressive's attempts to shred it sitting down. They're going to fight for it and they're going to win as they just did in Colorado.
| Fox News' Devastating Video Montage of Obama Administration's Statements On Syria Posted: 11 Sep 2013 11:37 AM PDT Get ready ... it's the Obama administration in full clown mode:
This is what you voted for?
| 9/11 Bikers in D.C. ... 'as far as the eye can see' (Video) Posted: 11 Sep 2013 11:03 AM PDT The National Park Service denied a permit for the bikers but had no problem with granting a permit to a Muslim group planning a rally Wednesday to supposedly "call attention to social justice issues." More accurately, the American Muslim Political Action Committee has scheduled a rally to draw attention to what they call 'unfair fear of Muslims after the Sept. 11 terrorist attacks.' Undeterred, the bikers came anyway, and the line of bikers arriving was, as one observer called it ... "far as the eye can see."  From The Washington Times: Thousands of bikers from around the country roared into the D.C. area on Wednesday in a show of support for Sept. 11 victims and in solidarity against a controversial Muslim rally on the Mall. The 2 Million Bikers to DC ride might have fallen short of 2 million strong, but the numbers were impressive. A line of shining chrome and steel bikes stretched about a third of a mile from the starting point at the Harley Davidson of Washington store just outside the District in Prince George's County. ... [...] "We're here for 9-11," said national ride coordinator Belinda Bee. "We are going to have a peaceful ride ... But there are people who are sick and tired of their rights and liberties being taken away." More here. As for those "million" Muslims that were supposedly going to show up ... well, they are a whole bunch short! The Muslims picked the wrong damn day for their political/ideological protest. As one of the bikers aptly noted, 9/11 is a day precious to the United States and its citizens. God speed to all the participating bikers, and God Bless America!
| Col. Oliver North on Obama's foreign policy: "He showed we have limp, flacid, low T foreign policy; Take the Resolute Desk out of the WH" (Video) Posted: 11 Sep 2013 08:38 AM PDT Col Oliver North slammed Obama last night on Greta saying that tonight's speech by Obama showed the world that we have a limp flaccid low T foreign policy. He went on to say that Obama does not deserve to sit behind the resolute desk. That desk he said should be taken out of the Oval Office:
Related: Putin vs. Obama Hat tip - No More Cocktails via MB
| Putin vs. Obama Posted: 11 Sep 2013 08:35 AM PDT | The 9/11 Army Posted: 11 Sep 2013 08:32 AM PDT "There is no such thing as leaderless resistance unless one is a lone wolf. Lone wolves and democracy will not win the day. Some will lead, some follow, the rest will get the hell out-of-the-way... or in the way. Regardless, at the end of the day, the "clans" will have to be united... and someone will lead." Battlefield USA There is no need for a leader unless there is an army to lead. On this 9/11/2013 there is no leader, but the army is there - and building. The Two Million Biker ride came about in protest of the Million Muslim march, but make no mistake, it is much more than that. It is one "clan" making it clear, on behalf of we, the people, that we are ready to take on any and all bent on destroying this country. TAKE OUR WARNING NOTICE - TODAY WE COME TO YOU ONLY in PEACE - FEAR US NOT TODAY - FEAR OUR RETURN And don't EVER think that we will forget!  |  |
Everest Trek Posted: 12 Sep 2013 04:28 AM PDT |
Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor Posted: 12 Sep 2013 03:21 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. This email was sent to smart_z64.weblogs@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |   |
Talenti® Gelato & Sorbetto Issues an Allergy Alert for Undeclared Allergen (Almonds) in Talenti German Chocolate Cake Gelato Pints Posted: 12 Sep 2013 03:20 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. This email was sent to smart_z64.weblogs@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |   |
Inform:Smart sharing of informations Posted: 11 Sep 2013 01:09 PM PDT |
September 11 Tales of Heroes and Tough Lessons Posted: 11 Sep 2013 12:39 PM PDT This email was sent to smart_z64.weblogs@blogger.com on behalf of: Government Printing Office (GPO) · 732 N Capitol Street, NW · Washington, DC 20401 · 866-512-1800 | 
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The Japan Travel Newsletter Special Edition: “Only in Japan” Sweepstakes is now open. Posted: 11 Sep 2013 12:22 PM PDT Is this email not displaying correctly? Try the web version. | | | | You are receiving this message because you requested information or voluntarily subscribed to our newsletter. Please do not reply to this message as replies to this email address are not read. | | |   |
N-2013-58: Monthly interest rates Posted: 11 Sep 2013 11:25 AM PDT   | IRS GuideWire | September 11, 2013 | | News Essentials What's Hot News Releases IRS - The Basics IRS Guidance Media Contacts Facts & Figures Problem Alerts Around The Nation e-News Subscriptions IRS Resources Compliance & Enforcement Contact My Local Office Filing Options Forms & Pubs Frequently Asked Questions News Taxpayer Advocate Where to File | Issue Number: N-2013-58 Inside This Issue Notice 2013-58 provides guidance as to the corporate bond weighted average interest rate and the permissible range of interest rates specified under § 412(b)(5)(B)(ii)(II) of the Internal Revenue Code as in effect for plan years beginning before 2008. It also provides guidance on the corporate bond monthly yield curve (and the corresponding spot segment rates), and the 24-month average segment rates under § 430(h)(2). In addition, this notice provides guidance as to the interest rate on 30-year Treasury securities under § 417(e)(3)(A)(ii)(II) as in effect for plan years beginning before 2008, the 30-year Treasury weighted average rate under § 431(c)(6)(E)(ii)(I), and the minimum present value segment rates under § 417(e)(3)(D) as in effect for plan years beginning after 2007. The rates in this notice reflect certain changes implemented by the Moving Ahead for Progress in the 21st Century Act, Public Law 112-141 (MAP-21). Notice 2013-58 will be published in Internal Revenue Bulletin 2013-40 on September 30, 2013. Back to Top Thank you for subscribing to IRS GuideWire, an IRS e-mail service. If you are a Tax Professional and have a specific concern about your tax situation, call the IRS Practitioner Priority Service 1-866-860-4259. This message was distributed automatically from the IRS GuideWire mailing list. Please Do Not Reply To This Message. | This email was sent to smart_z64.weblogs@blogger.com by: Internal Revenue Service (IRS) · Internal Revenue Service · 1111 Constitution Ave. N.W. · Washington DC 20535 |  |   |
MedlinePlus Health News Posted: 11 Sep 2013 11:14 AM PDT U.S. National Library of Medicine · 8600 Rockville Pike · Bethesda, MD 20894 · 888-346-3656 |   |
CDER New September 11, 2013 Posted: 11 Sep 2013 10:35 AM PDT  What's New on the FDA Drugs Site September 10, 2013 September 10, 2013 New and Generic Drug Approvals September 9, 2013 Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type | Biaxin | clarithromycin | Tablet; Oral | Abbvie | Labeling Revision | Biaxin | clarithromycin | For Suspension; Oral | Abbvie | Labeling Revision | Biaxin Xl | clarithromycin | Tablet, Extended Release; Oral | Abbvie | Labeling Revision | Children's Cetirizine Hydrochloride Allergy | cetirizine hydrochloride | Syrup; Oral | Perrigo R and D | Approval | Fortesta | testosterone | Gel, Metered; Transdermal | Endo Pharms | Manufacturing Change or Addition | Gralise | gabapentin | Tablet; Oral | Depomed Inc | Manufacturing Change or Addition | Levetiracetam | levetiracetam | Tablet, Extended Release; Oral | Sun Pharma Global | Approval | Oraverse | phentolamine mesylate | Injectable; Injection | Septodont Holding | Manufacturing Change or Addition | Rythmol Sr | propafenone hydrochloride | Capsule, Extended Release; Oral | Glaxosmithkline Llc | Manufacturing Change or Addition | This email was sent to smart_z64.weblogs@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |   |
16th Street Baptist Church Bombing Victims Bronze Medal Posted: 11 Sep 2013 10:29 AM PDT |
"Winging It" is Not an Emergency Plan Posted: 11 Sep 2013 09:48 AM PDT |
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