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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: blankmind who wrote (5063)1/28/1998 6:25:00 AM
From: MissLil  Read Replies (1) 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.
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