Great News For American Men Who Can't Get It Up: Cialis May Be Available Over The Counter Soon
Arthur Dominic Villasanta | | May 29, 2014 09:26 AM EDT |
Cialis 20mg
Guys who do Viagra know Cialis has a really awesome reputation for getting it up and keeping it up for a really long time.
That's why Cialis is the world's number one prescription drug for erectile dysfunction (ED). It posted $2.2 billion in global sales last year compared to rival Viagra with sales of $1.9 billion.
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Trouble is, both ED drugs need a prescription to be of any use. Cialis maker Eli Lilly and the company plan to change that through an agreement with French drug maker Sanofi S.A.
The deal being discussed will allow Sanofi to sell a non-prescription version of Cialis in major markets if regulators approve.
The key word is "if" but industry sources said the deal might materialize in 2017 when the patent for "tadalafil," Cialis' generic name, expires.
Sanofi is acquiring the exclusive rights to seek regulatory approval for over-the-counter (OTC) Cialis in the US, Europe, Canada and Australia.
It plans to begin selling the generic version after the expiration of certain patents for tadalafil. Patents are due to expire in 2017 in the US and Europe.
Sanofi, however, will have to convince the US Food and Drug Administration (FDA) that men can be trusted to use Cialis safely without a doctor's guidance.
The FDA said it needs to discuss with Eli Lilly and Pfizer, Inc., maker of Viagra, what kind of data it needs to support the switching of their ED drugs to OTC.
Cialis can cause a sudden drop in blood pressure if taken with certain heart and blood-pressure medications. It might also cause fainting or even death. The same is also true for Viagra.
Pfizer applied for European regulatory approval to switch Viagra to OTC status in 2007. It withdrew its application in 2008 after a regulatory advisory body revealed concerns the OTC version would be misused.
Sanofi's consumer health care division said the company will soon begin discussions with regulatory authorities to determine the best way to test OTC Cialis in support of regulatory approval.
Cialis has been used by some 45 million men since its introduction in 2003. Lilly and Sanofi said the availability of an OTC version will help curb the spread of fake or substandard Cialis advertised online.
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