Makers of erectile dysfuction drug Cialis seek OTC approval

The FDA would need additional research to sell the erectile dysfunction drug over-the-counter.

Cialis seeks OTC approval
Cialis seeks OTC approval

HealthDay News - Men with erectile dysfunction may soon be able to purchase treatment without a prescription.

The drug's maker, Eli Lilly, and French pharmaceutical company Sanofi have announced plans to request approval to sell Cialis over the counter once its patents expires.

The drug loses patent protection in the United States and Europe in 2017. If sold OTC, Cialis could gain an advantage over similar ED medications that are only available via prescription.

In 2008 Pfizer abandoned a similar plan for Viagra, after the European Medicines Agency raised safety concerns. Cialis, like other ED medications, should not be taken with some heart medications because it could cause an unsafe drop in blood pressure.

Clinicians have also raised concerns that marketing Cialis as an OTC product could result in missed opportunities to diagnose other serious health conditions like diabetes and heart disease, for which ED is an early warning sigh. 

The FDA still needs to decide what type of additional research will be required to market Cialis without a prescription.

References

  1. Thomas K.(28 May 2014.) "A Plan to Sell Cialis, an Erectile Drug, Over the Counter." New York Times. Retrieved from: http://www.nytimes.com/2014/05/29/business/eli-lilly-takes-step-toward-making-cialis-an-over-the-counter-drug.html
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