Pfizer withdraws application for OTC Viagra in EU

Pfizer believes that Viagra 50mg is a suitable candidate for non-prescription supply through pharmacists in the EU and meets the criteria set out by the European Commission guideline for changing the classification of a medicinal product to non-prescription.

However, in a letter to the European Medicines Agency (EMEA), Pfizer said that it has decided to withdraw the application in order to fully consider comments from the EMEA’s Committee for Medicinal Products for Human Use (CHMP), recognizing that there were some concerns regarding the proposed supply of Viagra 50mg tablets without a prescription in the EU. The CHMP noted that when Viagra is used in accordance with the currently approved prescribing information, its safety profile remains favorable.

The withdrawal of the application will enable evaluation of further information and additional data that may be required to allow any future assessments under the centralized procedure. Pfizer also believes that access to Viagra 50mg without a prescription in a pharmacy setting in the EU would provide valuable benefits to male patients suffering from erectile dysfunction.

Rory O’Connor, vice president of medical and regulatory affairs at Pfizer, said: “Viagra has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials. 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.”