SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: art slott who wrote (736)4/29/1998 2:18:00 PM
From: tommysdad  Read Replies (1) of 1837
 
Cenestin is "generic Premarin", is it not? They had to go for a branded drug because the FDA said DRMD's product is not equivalent to Premarin (I'm not making a judgement call here -- just reminding you of what happened). Hence "generic Premarin" became "Cenestin".

There really is no typical timetable for FDA response to an NDA. This is definitely not a fast-track drug, so look for a 6-9 month timeframe for approval. There are no updates -- i.e., don't expect the FDA to say "we're still looking at the NDA" every couple of months.

Since the FDA has already denied a generic Premarin ANDA, there is no realistic timetable for that . . .
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News