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December 19, 2008 | Evening Edition

Top Stories Bailout Brings Automakers In From The Cold President Bush Announces $17.4 Billion In Short-Term Loans For Struggling Autos  DNA Confirms Skeletal Remains Are Caylee  The "Detroit's A Loser" Myth  Obama Fills Out 4 More Senior Posts CBS News Programs The Early Show: Celeb Spot Jennifer Aniston: "It's My Time" Tells Harry Smith, "I'm Starting To Live; It's Good"  Early Show: Rush To Refinance -- Or Hold Off?  Early Show: Italian Christmas Feast, From A Master  Early Show: Hi-Tech Eyes On Your Home When You're Away U.S.  » More U.S. Storm Brings Wintry Misery Across U.S. Tens Of Thousands Lose Power, Hundreds Of Flights Canceled From Midwest To Northeast  Ex-Bush Aide Convicted In Abramoff Scandal  Caylee Crime Scene Was Reported In August  NASCAR Settles $225M Harassment Suit World  » More World Judge: Iraqi Shoe-Tosser Appears Beaten Investigating Judge Says Detained Reporter Has Bruised Face, Confirms Pardon Request  The Legacy Of Condoleezza Rice  Bolivia Announces Car Import Ban  France's First Lady Unplugged Politics  » More Politics Blagojevich Vows To Fight Charges Ill. Gov. Says He Won't Resign Amid Federal Corruption Allegations; Says He Has "Not Done Anything Wrong"  Obama Cabinet: Middle-Of-The-Road Dream  W. Mark Felt, "Deep Throat," Dies At 95  Ex-Bush Aide Convicted In Abramoff Scandal Health  » More Health New Ratings Put Spotlight On Nursing Homes 22 Percent Of Nursing Homes Get Minimum, One-Star Rating; 12 Percent Get Top Score  Study Debunks Conventional Wisdom  How One 11-Year-Old Kicked Cancer  "Head-Bangers" Risk Brain, Neck Injuries SciTech  » More SciTech Mars Find Suggests Life Once Possible Orbiter Spots Carbonate In Exposed Rock, Evidence Parts Of Planet May Have Been Hospitable To Life  Oil Demand Slowing, Says Energy Agency  67 Percent Say They Understand Their Pets  Apple Takes Bite Out Of Macworld Business  » More Business The True Price Of Auto Labor Costs While UAW Is Blamed For Detroit's Troubles, Comparison To Wages Paid By Foreign Carmakers Isn't Whole Story  Wall St. Up Modestly After Auto Bailout  Panasonic To Buy Sanyo In $9B Deal  Feds Take Swipe At Credit Card Rules Strange  » More Strange Cocaine Suspect Describes Himself To Texas Police Cocaine Delivery Suspect Arrested After Describing Himself To Texas Police  Stolen Cake Sparks Bank Data Alert In Germany  Man Finds Cash In Same Store Twice And Returns It  Hot Gold Puts Mich. Postal Worker In Hot Water Entertainment  » More Entertainment Jennifer Aniston: "It's My Time" Tells Harry Smith, "I'm Starting To Live; It's Good"  "Star Trek"'s Nurse Chapel Dead At 76  France's First Lady Unplugged  "Head-Bangers" Risk Brain, Neck Injuries Opinion  » More Opinion The Legacy Of Condoleezza Rice Charles Wolfson Analyzes The Rhetoric And Reality Behind The Secretary Of State's Tenure  Do We Need A Detroit Bailout? Really?  Obama's First Task: Restore Credibility  Newsweek Is In Decline

Top Videos  » More Videos Blagojevich: I Did Nothing Wrong (3:06) Perez Hilton's 2008 Best And Worst (1:09) Clinton At State, A Done Deal? (3:44) Bush Bails Out Autos (4:40) Chertoff: Security "Worked" (4:43) Jennifer Aniston Talks Yoga (4:41) Top Photos  » More Photos Photos Of The Day Celebrity Circuit "Wrestler" On Two Coasts In Royal Circles Versace's Vision Bush's Final Trip To Baghdad Latest Blog Posts  » More Blogs Political Hotsheet Obama On Auto Bailout: "Patience Is Running Out" President-Elect Weighs In On President Bush's Plan During Friday News Conference Read More Couric & Co. A Public Hanging (Of Sorts) For The Bush Family President Bush And First Lady Laura All Jokes At National Portrait Gallery Painting Unveiling Read More World Watch Zimbabwe's Blind Eye To Cholera Sky News Takes A Candid Look At The African Nation's Desperate Situation  Read More Most Viewed Stories 1. Study Debunks Conventional Wisdom 2. Alleged Murder-For-Hire Rattles Small Town 3. A Second Mortgage Disaster On The Horizon? 4. Bush Considers "Orderly'' Auto Bankruptcy 5. Caylee Crime Scene Was Reported In August Videos 1. A Meal To Die For (5:11) 2. The Mortgage Meltdown (12:29) 3. Small Town Hit List (6:05) 4. A Different Kind Of Coach (12:44) 5. Evening News Online, 12.18.08 (21:01) Photos 1. Celebrity Circuit 2. Photos Of The Day 3. Celebrity Circuit 4. "Wrestler" On Two Coasts 5. Presidential Program

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HIV/AIDS Update - Tentative approval of abacavir sulfate and lamivudine fixed-dose combination

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On December 19, 2008, FDA granted tentative approval for fixed-dose combination scored tablets, made by Aurobindo Pharma Limited' of Hyberdad, India, containing abacavir sulfate and lamivudine, 60mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, . The tablets are dispersable in water, intended for pediatric patients 3 months - 16 years of age.

Abacavir sulfate and lamivudine are members of the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class of anti-viral drugs. Fixed-dose combination products such as this one can help facilitate shipment, storage, and multi-drug treatment for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under the President's Emergency Program for AIDS Relief, or PEPFAR. 

FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 

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Breaking News Fri., December 19, 2008

Breaking News from ABCNEWS.com:

Blagojevich Proclaims Innocence, Says 'I Will Fight, I Will Fight, I Will Fight' [3:12 p.m. ET]

For more, go to abcnews.go.com?CMP=EMC-1396

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Michael Markarian: Animals & Politics

Talk Back: From Puppies to Palin Posted: 19 Dec 2008 10:45 AM CST Today I'd like to share some of your comments in reaction to my recent blog entries, on a wide range of issues affecting pets, farm animals, and wildlife. The first comment came after I posted my blog on the use of taxpayer dollars to stock tame pheasants for sport hunting: Thank you for this post. I'm a lifelong Illinois resident and had no idea my tax dollars had been going to this type of operation. I'm also going to keep this in my records for when hunters talk about killing animals to prevent them from starving to death.—Tracy In response to the video of Sarah Palin's interview while a turkey was slaughtered in the background: Palin's behavior on this video is indicative of so many people in this and other countries—people who have not woken up to the fact that animals such as turkeys and pigs and cows and chickens and horses should enjoy the same basic protections as humans. Why is cruelty to animals allowed but cruelty to humans punishable by law? Why are puppy mills and rodeos and circus acts and dog racing legal? We all need to wake up and change the way we see and treat animals—if only for the fact that if an individual can accept or partake in cruelty to animals, they just might have it in them to do the same to people. I have a letter out to Palin as we speak. I am praying she doesn't become any more powerful than she is today.—Michael B. In response to the investigation revealing that Petland retail stores support puppy mills: I too have asked the employees and managers of the Petland store here in my area if their puppies come from breeding mothers at puppy mills and they all told me the same thing, that they absolutely do not get their puppies from puppy mills, but from reputable breeders. The HSUS puppy mill/Petland investigation once and for all puts those doubts to rest for sure! We're doing our part here in Plano to educate the citizens about a veterinarian who works with Petland. The vet's wife told me that they don't like their names thrown around on the street. I told her, "Well, we don't like dogs suffering in cages breeding over and over for pet shops either!" I'm keeping the faith that not only more laws will change for the breeding mothers at puppy mills, but that consumers will realize they have the power to end this atrocity as well.—Pamela B. THANK YOU for uncovering and documenting this abuse. I have contacted my local Petland store plus corporate office on this matter. As a volunteer humane educator I try to educate people of all ages on this epidemic. Great job HSUS...keep it up!!!!—Helene In response to President-elect Obama's desire to adopt a shelter dog and his participation in Jana Kohl's book, A Rare Breed of Love: You cannot imagine how happy I am to see President Obama with a little poodle rescued from a puppy mill. I have been voicing my outrage so often to the governors of different states and I am deeply disturbed that puppy mills still exist. I am so happy to know that Barack Obama may finally do something about this terrible and inhumane problem. I am so happy to learn that he is very much aware of this. He is our best hope to put an end to all the suffering of all these beautiful dogs.—Elisabeth S. Thank you all for submitting these comments, and please keep the feedback coming. If you have a question or comment and would like to join the conversation, please send me an email.

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Obama Should Worry About Iraqi Shoes, Too | It's Official: The U.S. Lost the War

War on Iraq Newsletter December 19th, 2008 More from War on Iraq »

Obama Should Worry About Iraqi Shoes, Too By Ben Lando, AlterNet When Iraq's violence escalates, President Obama better not be caught on his heels when he's blamed for losing Bush's "win." Read more »   The big story of the week was Iraq's shoe-throwing journalist, Muntader al-Zeidi, but another report just came down with important implications for the future of the occupation. The Washington Post reports: An internal State Department report says Blackwater Worldwide may lose its license to work in Iraq and recommends that the agency prepare alternative means to protect its diplomats there. ... The 42-page draft report by the State Department's Inspector General says the department faces "numerous challenges" in dealing with the security situation in Iraq, including the prospect that Blackwater may be barred from the country. The department would have turn to other security arrangements to replace Blackwater, officials said. This comes at a moment when five Blackwater operatives involved in the deadly massacre at Baghdad's Nisour Square last September have been indicted for their actions, which left 17 Iraqi civilians dead and more than 20 wounded. Keep visiting AlterNet's War on Iraq section for more news on Blackwater, mercenaries -- and, of course, Muntader al-Zeidi. Thanks for reading, Liliana Segura Editor, War on Iraq Special Coverage     From U.S. War Resisters, A Letter of Solidarity to Israeli Army Resisters AlterNet About 100 Israeli high school students have declared their refusal to serve in the Israeli army and participate in the occupation of Palestine. Read more »   Foreign Mercenaries Losing Their Immunity in Iraq By Willam Fisher, IPS News Under the agreement approved by the Iraqi government last week, U.S. contractors will be subject to Iraqi law for the first time. Read more »   Kids Learn that Killing Is Fun at the Army's Lethal New Theme Park By Penny Coleman, AlterNet The Army's new recruitment tool lets high-tech video game centers desensitize, condition, train and even enlist America's youth. Read more »   It's Official: Total Defeat for U.S. in Iraq By Patrick Cockburn, CounterPunch Iraq's parliament came to a major agreement recently: all 150,000 troops are to withdraw from cities by June. Read more »   Economy, Relations with West Are Key to Iran's 2009 Elections By Gareth Porter, IPS News Both Mahmoud Ahmadinejad and whoever is chosen as his opponent are expected to try to pin responsibility for Western sanctions on each other. Read more »   Even the State Department Recommends Dumping Blackwater By Satyam Khanna, Think Progress A panel commissioned by Secretary of State Condoleezza Rice has called for the security firm's contract not to be renewed next year. Read more »   PEEK and Video: The hottest buzz and videos on the web     Iraq Ambassador Addresses Growing Demand to Free Iraqi Journalist By Staff, CODEPINK Women for Peace: Action Blog CODEPINK takes action to support al-Zaidi and his anti-war sentiment. Read more »   Revealed: Unpublished Fed Document Highlights Costly Rebuilding Blunders in Iraq By dday, Hullabaloo The people who were given the task of rebuilding Iraq had absolutely no interest in doing so. Read more »   Shoe-Throwing Iraqi Journalist 'Beaten in Custody' By Faiz Shakir, Think Progress Al-Zaidi's brother reports that the journalist is suffering from a broken hand, broken ribs, and internal bleeding. Read more »   Meet the Man Who Threw His Shoes at Bush: Muntader al-Zeidi By Hanna Ingber Win, Huffington Post Learn more about the man who threw the 'shoes heard round the world,' and find out what's happening to him now. Read more »

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Breaking News Fri., December 19, 2008

Breaking News from ABCNEWS.com:

Florida Authorities Identify Remains as Missing Toddler Caylee Anthony [2:03 p.m. ET]

For more, go to abcnews.go.com?CMP=EMC-1396

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