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Viagra approved for sale in Australia.



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Media release

 

The Hon Dr Michael Wooldridge

Minister for Health and Family Services

 

MW 189/98

27 August 1998

 

VIAGRA APPROVED FOR SALE IN AUSTRALIA

 

Pfizer Australia Pty Ltd has been given the green light for the sale of Viagra in Australia subject to the company amending the product information to include a health warning, following approval by the Australian Drug Evaluation Committee (ADEC), the Federal Minister for Health and Family Services, Dr Michael Wooldridge, announced today.

 

Viagra (sildenafil citrate) is a new drug for the treatment of erectile dysfunction in males, and is undergoing further clinical trials in Australia and overseas for the treatment of female sexual dysfunction.

 

Dr Wooldridge said that Viagra would be available for sale in pharmacies as soon as the manufacturer was able to modify the packaging to contain a health warning recommended by ADEC in the light of a number of interactions with cardiac conditions.

 

ADEC has recommended that there be a boxed warning which will read: “The use of viagra in men with cardiac disease has been associated with sudden death. The concomitant use of nitrates and Viagra is contraindicated”.

 

Dr Wooldridge said he believed many Australian men would welcome the availability of Viagra in the Australian market.

 

“The Government has fast-tracked the decision-making process that is undertaken by independent experts with respect to Viagra,” Dr Wooldridge said.

 

“There has been widespread media coverage of this new drug following its US launch earlier this year, and there is very obviously great demand for the benefits it brings to men who have difficulty achieving an erection.

 

“We wanted to make sure that a decision was reached as soon as possible to prevent the growth in a black market or via the Internet.

 

“It is a credit to the independent experts that they have made a speedy decision after weighing all of the clinical evidence, and also that Australia will be leading the world in making sure that there is a responsible health warning on the packaging.

 

“We certainly want Australian men to have access to Viagra and its performance-enhancing benefits, but we want to ensure that it is used wisely and that people with heart conditions are aware of the risks,” Dr Wooldridge said.

 

ADEC approval allows Pfizer to market and sell Viagra in Australia, but does not automatically lead to listing as a subsidised drug on the Pharmaceutical Benefits Schedule. That is a separate application to the Pharmaceutical Benefits Advisory Committee.

 

Media Contact: Bill Royce Dr Wooldridge’s office (02) 6277 7220

 

 

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