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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: Edderd who wrote (19733)3/14/1999 10:51:00 AM
From: BigKNY3  Read Replies (1) | Respond to of 23519
 
Edderd: <<I don't remember Viagra ever mentioning MUSE. >>

Ed: This is from the precautions section of Viagra's labeling:

"The safety and efficacy of combinations of VIAGRA with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended."

Ed and DaiS, here is a FDA Website "From test tube to patients that will provide useful facts on the FDA process for approving new drugs and new indications for previously approved products.
fda.gov

Note the following:

-It takes an average of 6 1/2 years to research and study a new product before a NDA review even begins.

-Out of 100 investigational new drug applications submitted to the FDA, only 20 "will ultimately be approved for marketing".

Moreover, under current FDA regulations, EVERY pharmaceutical product must undergo Phase I and Phase II safety studies. This includes FDA approved products that are being tested for new indications, as new dosage administration forms or in new patient groups. The scope of these studies may vary following discussions with the FDA.

Here again are some interesting 1998 Websites with background information on FSD including an interview with Dr. Jennifer Berman who was featured on last Friday's 20/20 segment:

abcnews.go.com

archive.abcnews.go.com

cnn.com

BigKNY3