Duramed (DRMD) Synthetic Estrogen Product Message Board

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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product

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To: johnlag who wrote (944)	3/25/1999 3:01:00 PM
From: Doug Bean	of 1837

Johnlag: yes it was approved for limited symptoms,, thats all they applied for. Some peole don't get it but,,, this is just a foot in the door to get their whole package approved. Just think they now have an approved conjugated product from which to grow the product line! they can't get it approved for long term bone loss prevention etc without longer term testing. They were just saying to the FDA " hey, all we're saying is that our product prevents this and that etc etc thats all ,, we are not saying it will replace Premarin,, just thta it does this.. Its hard to turn that down because they had the tests to prove it did those things ( flashes and sweats) those are short term effects that you can prove easily. Now they can turn their attention to the longer term uses and expand on the product line. Don't be disappointed , be happy. CRDoug To get it approved for this limited usage allows them to make big profits and do long term testing after which they will apply for expanded labeling. Also they are in tests with other products combined with Cenestion for other usages

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