Viagra Stays Behind EU Counters
Pfizer withdraws application to sell drug without prescription after it hits opposition from government panel.
Pfizer decided on Thursday that it was too difficult to achieve over-the-counter status for Viagra in Europe.
The pharmaceuticals said it was withdrawing its application to switch the erectile-dysfunction medication from its current prescription status in the European Union.
Pfizer (nyse: PFE – news – people ) was quick to point out that it believes Viagra meets all the criteria for nonprescription status under the European Commission’s guidelines, but decided to withdraw the application after concerns were raised by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The company did not elaborate on what the committee’s concerns were and did not return requests for comment.
“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.”
Shares of Pfizer were down 7.1%, or $1.11, to close at $14.45, on Thursday, a day when the market was down drastically overall. According to an industry index kept by Revere Data, biopharmaceutical companies were down 5.4%.
Pfizer said it will take this opportunity to assess what further data might be needed for the application process in the future. Viagra had third quarter sales of $509.0 million worldwide. It is also sold under the name Revatio for the treatment of high blood pressure.
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