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Companies Seek OTC Approval for Erectile Dysfunction Drug, Cialis

Update Date: May 28, 2014 09:34 AM EDT
Cialis
Sanofi is in the process of getting exclusive rights to ask for regulatory approval of OTC Cialis in the U.S., Canada, Europe and Australia. (Photo : Wiki Commons)

Erectile dysfunction drug, Cialis could soon be available over-the-counter (OTC) after its manufacturer, Eli Lilly & Co signed a licensing deal that could give Sanofi SA permission to sell the drug without a prescription. French drug maker Sanofi now needs to get approval from regulators.

Both companies believe that if the nonprescription drug gets OTC approval, men who suffer from the condition would have easier access getting the care they need. The availability of the drug could also reduce the likelihood that people will buy Cialis online. Studies have found that some men have a hard time talking about ED with their doctors and instead of getting a prescription, they risk buying fake or stolen drugs through the Internet.

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"The experience we have in the prescription setting gives us confidence in the nonprescription setting," David Ricks, who heads Lilly's biomedicines unit, said reported in the Wall Street Journal. "Many men don't go all the way through the process of making an appointment with a doctor and securing a prescription through a legitimate pharmacy,

Getting approval will not be an easy task. Sanofi must provide evidence that men with ED will know how to use the drug correctly and safely. One of the side effects of Cialias is a sudden drop in blood pressure when taken in combination with other heart and blood pressure drugs. Sanoif will have to demonstrate to the regulators that men are aware of this risk as well as others when taking Cialis.

Sanofi is in the process of getting exclusive rights to ask for regulatory approval of OTC Cialis in the U.S., Canada, Europe and Australia. The company hopes to start selling the product after patents for Cialis, generically known as tadalafil, expire. The patents start expiring in 2017.

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