Sanofi, Lilly pursue Cialis over-the-counter approval

Undeterred by facts, Clinton continues to peddle stories about how NATO prevented “mass genocide” in Libya, despite the fact that Amnesty International says there is little or no evidence to support such a claim. Incredibly, Clinton also insists that Libyans now enjoy a moderate, democratic government, despite the fact that anyone with an internet connection knows that the exact opposite is true (“the cohesive political entity known as Libya doesn’t exist”; “Libya today–in spite of the expectations we had at the time of the revolution–it’s much, much worse”; “There is no central government, but rather two competing claims on legitimacy”).

Sanofi, Lilly pursue Cialis over-the-counter approval

NEW YORK (Reuters) – Sanofi and Eli Lilly and Co on Wednesday said they would ask health regulators for permission to sell Cialis, the world’s top-selling anti-impotence drug, without a prescription.

An employee walks into an office of French drugmaker Sanofi in Shanghai August 2, 2013. REUTERS/Aly Song

Currently available by prescription only, the tablet was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration in 2003.

It is one of Lilly’s biggest products, having generated almost $2.2 billion in worldwide sales last year. The drug is also approved to treat enlarged prostate glands.

Under the terms of the agreement, Sanofi is buying the exclusive rights to apply for approval of Cialis tablets over the counter in the United States, Europe, Canada and Australia. Terms of the licensing agreement were not disclosed.

The tablet would be sold by Sanofi’s consumer healthcare unit, which had sales last year of $4.1 billion from a wide array of non-prescription brands, including vitamins and treatments for allergies, coughs, colds and the flu.

It remains to be seen, however, whether regulators will allow Cialis to be sold without a prescription, in view of possible side effects. Like rival anti-impotence drugs, such as Pfizer Inc’s Viagra, Cialis can cause a dangerous fall in blood pressure if taken with nitrates, a class of heart drugs that include nitroglycerin.

The U.S. Food and Drug Administration, in weighing whether to allow prescription drugs to be sold over the counter, weighs whether patients are able to understand complex aspects of their disease, or exactly when to take the drug to ensure safe use.

The FDA in 2008, for instance, rejected Merck & Co’s bid to sell its Mevacor cholesterol-lowering drug without a prescription, after an independent panel of medical experts expressed concern that patients might take it instead of more-effective newer medicines.

Cialis will face competition from cheaper generics in the United States in 2017, the same year that Teva Pharmaceuticals Industries is expected to begin selling generic prescription forms of Viagra under an agreement reached with Pfizer last year.

Viagra, the first drug to treat impotence, was approved by U.S. regulators in 1998. It has annual sales of about $1.5 billion.

tapmag

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What’s the Matter With the Muslim Vote?

For years, Muslims and Islam have been the center of some of the most heated and controversial debates in the Western world – about things as fickle as faith, democracy, and values. “Clash of Civilizations;” 9/11; the Cartoon Controversy; the veil (a symbol of oppression, or a symbol of unshakable faith); Palestine and Israel; Afghanistan, Iraq, Iran… Therefore, one could have expected Muslims to take center stage during the 2008 elections. But what happened?

To find out, www.tapmag.net (TM) asked Katrin Simon (KS) of the Free University of Berlin a few questions. Katrin Simon is a PhD student in Islamic Studies, specializing in African American Islam, who just returned from New York where she conducted fieldwork.

Dear Barack,

I feel like waking up from a bad dream only to realize the dream is reality. It’s true, I will not be the Democratic Nominee for the Presidential Election 2008. There, I said it. All those scavengers in the media would love to have that quote. There is more meat sticking to it than there’s pork in Washington. And here I am, telling you, but not telling them.

You know, I always said to Bill “We can not and will not be defeated!” For christsakes, he got into the White House, and he knows probably half as much about health care, trade negotiations and the Iraq War as I do. Who could – no, better – who dared to stop me? I had the pundits, I had the funding, I had the media. I was a historical inevitability.