To: Anthony Wong who wrote (5155 ) 8/24/1998 10:59:00 PM From: BigKNY3 Read Replies (3) | Respond to of 9523
Anthony: Here's the report from the Financial Times. Have PFun! BigKNY3 _________________________________________ WORLD NEWS - EUROPE Viagra set to be cleared for sale By Neil Buckley in Brussels and Michael Peel in London 08/25/98 Financial Times London Edition Page 2 Viagra , the anti-impotence drug, could be cleared for sale in the European Union within weeks, after winning approval yesterday from an EU scientific committee. The EU's standing committee on medicines, made up of representatives of the 15 member states, gave the go-ahead for Viagra to be marketed, clearing the way for final approval by Martin Bangemann, industry commissioner. Commission officials suggested Mr Bangemann's decision was likely by September 15, or even earlier, allowing time for the approved instructions for the drug to be translated into 11 EU languages. Viagra won approval from the US Food and Drug Administration in March, and has become one of the biggest-selling drugs in history. EU consumers in search of supplies have so far had to rely on internet sales, or visits to countries such as Andorra or Switzerland where the drug is available. The approval from EU states' representatives follows a positive opinion in May from the London-based European Agency for the Evaluation of Medicinal Products (EMEA) on a marketing application from Pfizer UK, and Roerig Farmaceutici, both subsidiaries of Pfizer of the US, which developed Viagra . The EMEA said Viagra should be available only on prescription, to men with no history of cardiac problems who have undergone a medical examination. Professor Rolf Bass, head of the EMEA's human medicines evaluation unit, said yesterday's decision was the "main step" in securing final approval. But he suggested the decision was not unanimous, but had been taken to a vote. Germany, reported earlier to have concerns over the drug following the deaths of six users in the US, is understood to have pushed successfully for more information about contra-indications to be included in the instructions. Pfizer UK called yesterday's decision "another major hurdle we have leaped over". "We don't see anything outstanding that could ultimately prevent us from getting the licence," it said