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

To: blankmind who wrote (5063)	1/28/1998 5:10:00 AM
From: RCVJr	Respond to of 23519

I'm sure TA may be able to answer this question better but the delivery system Muse by VIVUS was approved by the FDA. The factory that manufactors Muse must also be approved by the FDA for manufactoring of the applicator/drug. If a new plant is built, the plant must undergo the same sort of inspection to assure proper quality control is being maintained. I'm sure the first plant was approved before they (VIVUS) could sell any of its product.

To: blankmind who wrote (5063)	1/28/1998 6:25:00 AM
From: MissLil	Read Replies (1) \| Respond to of 23519

re: plant approval Question: why does Vivus' 2nd plant need FDA approval? Did the 1st plant also need to be fda approved at some point? If so, when? After MUSE was approved? Answer: The first plant would have had to have been approved prior to the initial FDA approval. The second plant (I believe) would need to be approved prior to the release of product to the US. Some other countries do not have their own FDA-type institution or it does not have the technical resources to evaluate products and they rely on FDA approval. Given the problems this plant and others have, it should be clear why such is necessary. A special department, Chemistry, takes care of these approvals in the FDA with consultations with other specialists as necessary. Microbiologists review the sterility data. If anyone needs more details, I can find out easily.