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Viagra remains prescription-only in Europe

20 Nov 2008

Regulatory Affairs

Pfizer has withdrawn its bid to make Viagra available without a prescription in the European Union (EU).

The company revealed it is no longer applying to change the status of the 50 milligram (mg) tablet strength while it considers comments from the European Medicines Agency (EMEA), which had expressed concerns about the move to make it a non-prescription drug in the EU.

Pfizer maintained that making the 50 mg dosage available without prescription would bring "valuable benefits" to patients.

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."

He added that the company will continue to work with European regulatory authorities as part of its efforts to increase the availability of its medicines.

Pfizer was in the news last week as it launched a new research unit known as Pfizer Regenerative Medicine.

The drugs giant said the facility will enable its scientists to build on recent progress in their understanding of the biology of stem cells and any associated therapeutic opportunities that may bring.