Pfizer drops application to switch Viagra to OTC

NEW YORK Pfizer has withdrawn its application to switch 50 mg Viagra tablets from prescription to OTC in the European Union, the drug maker announced Thursday.

The company said it considers Viagra a suitable candidate for OTC availability and meets the European Commission’s criteria for OTC switches.

However, in a letter to the European Medicines Agency, Pfizer said it would withdraw the application to fully consider comments from the EMEA’s Committee for Medicinal Products for Human Use, recognizing that there were concerns regarding the proposed supply of the tablets without prescription in the EU. Pfizer said the withdrawal would allow evaluation of further information and additional data that may be required to allow any future assessments.

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