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To: Anthony Wong who wrote (988)	11/6/1998 8:02:00 AM
From: Anthony Wong	Respond to of 1722

[JNJ] Benecol talks with FDA productive - McNeil Friday November 6, 3:10 am Eastern Time HELSINKI, Nov 6 (Reuters) - McNeil Consumer Products said its meeting with the U.S. Food and Drug Administration (FDA) over the launch of its cholesterol-cutting food ingredient Benecol on Thursday had been productive. ''The meeting was productive. McNeil Consumer Healthcare presented new scientific information and revised labelling,'' the company, a division of Johnson & Johnson (NYSE:JNJ - news), said in a statement. McNeil and the FDA have disagreed over whether Benecol, developed by Finnish food and chemicals group Raisio , is a dietary supplement or a food product. The FDA has maintained that Benecol is a food product and must meet more stringent regulatory criteria than a dietary supplement. ''McNeil Consumer Healthcare has agreed to further discussions with the FDA as soon as possible to reach a conclusion leading to marketing of the product,'' it said. A Raisio spokesman told Reuters he was unable to specify what concessions McNeil had made to the FDA, but said Raisio was confident the talks were proceeding well. Benecol's first U.S. test launch in Oregon on Tuesday was cancelled but the nation-wide roll-out is still scheduled for January.

To: Anthony Wong who wrote (988)	11/6/1998 8:03:00 AM
From: Anthony Wong	Respond to of 1722

Singapore OKs Sale of Viagra Friday November 6 5:03 AM ET SINGAPORE (AP) - Singapore has approved the sale of the anti-impotence drug Viagra for an initial evaluation period of six months, the country's health ministry said Friday. After months of trials, the government has ''decided to take a cautious approach towards its introduction'' of the little blue pills because of reported deaths associated with use of the drug in the United States, the Ministry of Health said in a statement. The impotence remedy will only be available by prescription in Singapore and doctors are required to report any adverse reactions by patients to the health ministry. Singapore will also require the U.S. pharmaceutical company which makes the drug, New York-based Pfizer Inc. (NYSE:PFE - news), to submit monthly reports on the amount of Viagra it supplies to the island republic. ''The ministry will monitor the supply of Viagra to deter excessive utilization and abuse,'' the statement said. The permit allowing sales of Viagra will be reviewed at the end of the six-month period. Demand for the drug prior to government approval led to the creation of a thriving black market for Viagra pills smuggled into the country from overseas. dailynews.yahoo.com