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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Evan Dimmer who wrote (4275)1/4/1998 5:01:00 PM
From: BigKNY3  Read Replies (1) of 23519
 
Evan: <<Do Viagra (Pfizer) and Vasomax (Zonagen) have to get the same kind of approval from the individual countries too? If so, have either gotten that yet? I assume that Viagra hasn't, based on the fact that it isn't even out in the U.S. yet. Is this correct?>>

Evan: The European Medicines Evaluation Agency reviews pharmaceuticals for the major European companies.

Vasomax has not been submitted to any regulatory agency. Schering is currently guiding the NDA and European submissions for Vasomax.

Regulatory applications for Viagra were submitted three months ago on September 29, 1997 by Pfizer to the FDA and the European Medicines Evaluation Agency. On October 21, 1997, The FDA notified Pfizer it will be giving Viagra a "priority review" . Accordingly, this review will occur sometime in the first half of 1998. Viagra is currently not approved anywhere in the world.

David Chanin: The Viagra patent is owned by Pfizer with protection from generic competition for at least the next 10 years.

Hope these facts are helpful!

BigKNY3
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