Duramed (DRMD) Synthetic Estrogen Product Message Board

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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product

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To: Doug Bean who wrote (888)	2/9/1999 11:50:00 PM
From: tommysdad	Read Replies (1) of 1837

You really don't want them saying anything about Cenestin. The FDA has already "ruled against" the drug, when DRMD was going after generic Premarin status. Anything the company says at this point is only going to get FDA mad, and you really don't want that. Even if ruled "approvable", FDA can still come back and make DRMD jump through all kinds of hoops to get marketing clearance ("we don't like the chemical name you're using here" "we want you to change the font size on the package insert in this section"). No news is good news right now . . .

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