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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product
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To: art slott who wrote (762)6/24/1998 10:46:00 AM
From: tommysdad  Read Replies (2) of 1837
 
Duract was recalled, voluntarily by AHP, because of deaths due to misuse. The FDA probably would not act to withdraw this drug, just as they are not asking Pfizer to withdraw Viagra because some old men are dying due overexertion/interaction with other drugs.

The FDA does a good job overall. There were legitimate issues with "generic Premarin" -- I personally did not agree with the FDA decision, but if you actually read what the FDA put out and study the science a bit, it is clear that there were legitimate issues that were raised. In fact, DRMD itself did not dispute the science, just the FDA interpretation of some paperwork.

That said, there seems to be no reason to suspect that Cenestin will not get approval.
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