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Pfizer withdraws Viagra OTC application

Pfizer has withdrawn its application for Viagra, its erectile dysfunction treatment, to be made available without a prescription

Pfizer has withdrawn its application for Viagra, its erectile dysfunction treatment, to be made available without a prescription.

Viagra has been available on prescription in the EU for over 10 years. During this time, over 35 million men have used the drug worldwide.

Pfizer submitted an application to the European Medicines Agency (EMEA) for Viagra to be made available over-the-counter (OTC) in pharmacies. The company believes this would benefit thousands of men who may be too embarrassed to seek treatment from their doctors. The move would also help to reduce the number of men buying uncontrolled and counterfeit medicines from sources such as the internet.

The EMEA's Committee for Medicines for Human Use (CHMP) has raised concerns that the availability of Viagra without a prescription, and therefore without a clinical appointment, may mean that underlying conditions such as heart disease go unnoticed. In light of these comments, Pfizer has withdrawn its application in order to gather and analyse additional information.

"Viagra has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials," said Rory O'Connor, Pfizer vice president of medical and regulatory affairs. "We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies."

Viagra continues to be available on prescription, and the withdrawal of the OTC application at this stage will have no impact on any future applications relating to the drug that the company may submit to the EMEA.

20th November 2008

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