Duramed (DRMD) Synthetic Estrogen Product Message Board

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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product

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To: Thure Meyer who wrote (647)	3/14/1998 6:02:00 AM
From: vestor	Read Replies (1) of 1837

DRMD previously went in with an ANDA application. They were seeking bio-equivalency. However in a close vote they were denied due to the absence of an inert substance. DRMD maintained that the absence did not affect the efficacy. Now as an NDA I believe they will prevail despite the forces against them...Any idea as to how long it will take to know ?

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