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Viagra Going Over the Counter — in Britain

Move comes as generics approach U.S. launch

Viagra

Phanie/Alamy Stock Photo

The 50mg dose of Viagra will become available to anyone in the UK over the age of 18.

As a generic version nears launch in the U.S. market, erectile dysfunction pill Viagra will be available over the counter in the United Kingdom next year after its manufacturer, Pfizer, got approval Tuesday from British regulators.

"Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects,” Mick Foy, group manager of vigilance and risk management of medicines for Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA), said in a statement announcing the action.

The move will make the 50mg dose of Viagra available to anyone in the UK over age 18 — after they consult with a pharmacist. Viagra initially was developed as a potential treatment for high blood pressure and angina; among other potential health issues, it can cause sudden drops in blood pressure when used in combination with some commonly prescribed drugs.

A pharmacist will determine if Viagra is an appropriate treatment and can give advice on its usage, MHRA decided. 

Counterfeit and unapproved erectile dysfunction treatments are a worldwide problem. MHRA says its investigators have seized about $67 million worth of counterfeit and unlicensed erectile dysfunction drugs in the past five years.

MHRA actions sometimes have been a harbinger of subsequent moves by the U.S. Food and Drug Administration, but in this case, the body is the first in the world to approve Viagra for over-the-counter use, Reuters reports.

The move comes as generics near the market in the U.S. for both Viagra and a competitor, Cialis. Teva Pharmaceuticals, under an agreement with Pfizer, is launching a Viagra generic in the U.S. in December, while Cialis manufacturer Eli Lily has patent protection on the drug until September 2018. Both continue to require a doctor’s prescription in the U.S.

Viagra has been prescribed to more than 64 million men worldwide since first entering the market in 1998, trade publication the Pharmaceutical Journal reported in May. Despite its longtime status in the market, Viagra still brought in $996 million in the first three quarters of this year, Pfizer reported.

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