Sanofi Could Seek Regulatory Approval for Cialis OTC Status

Sanofi Could Seek Regulatory Approval for Cialis OTC in United States

Sanofi and Eli Lilly will work together to get regulatory approval for Cialis (tadalafil) from prescription drug to over the counter. The drug widely prescribed for erectile dysfunction was first approved in year 2002 by the European Medicines Agency.

Cialis accounted for $2.2 billion in sales last year in the US market. Cialis patents could expire in year 2017. The pharmaceutical majors are expecting higher sales if the US FDA approves the drug for Over the counter status.

Commenting on the agreement signed by Sanofi and Eli Lilly, Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi, said, "This agreement provides us with an opportunity to work with Lilly, a leader in men's health, to transform how this important medicine is offered to millions of men throughout the world.”

As per health data from Bloomberg School of Public Health, nearly 18 million men in the United States suffer from erectile dysfunction. Cialis also generates high amount of illegal online sales. If the drug is made over the counter, the online sales would decline, leading to easier availability of the drug across the country.

FDA review panel will check the risk factors associated with the drug. Also, the company might be asked to alter the warning labels. Pharmaceutical major Pfizer failed to get over the counter status for Viagra for the European market.

Cialis has less side effects compared to Viagra and also is considered safer medication. Cialis was approved by the U.S. FDA in year 2003.


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