Pfizer announced today that it has withdrawn its EMEA application to sell a low-dose version of its ED drug Viagra as a non-prescription medication. Pfizer said that the drug meets the criteria for changing the classification to a non-prescription medication, but that the application withdrawal decision was based on "concerns" expressed by the EMEA's advisory committee.
"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," the company said in a release.
Pfizer's statement also indicated that they may re-submit the application at a later date. "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."
- check out the Pfizer release