Psycho-Babble Medication Thread 882749

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eplivanserin; time estimate for possible release?

Posted by iforgotmypassword on February 27, 2009, at 2:02:27

"Among the applications for approval, the application of CiltyriŽ (eplivanserin), in the treatment of sleep disorders, was submitted to the FDA and the EMEA during the fourth quarter of 2008 and accepted for filing."

from the sanofi-aventis website:
http://en.sanofi-aventis.com/research_innovation/rd_key_figures/rd_key_figures.asp

based on it having been "submitted to the FDA" (an NDA?), if this drug is accepted, does anyone know when we might hear the news, and when it might be available for prescription?

if it releases in the US, is there anything to go by on whether it will be formally available in canada and when? this sort of thing tends to be unpredicatble, at least to me, since i do not know how everything works, or if it's all just (willed) government incompetence or corruption.

 

Re: eplivanserin; time estimate for possible release?

Posted by Netch on February 27, 2009, at 6:57:00

In reply to eplivanserin; time estimate for possible release?, posted by iforgotmypassword on February 27, 2009, at 2:02:27

"EMEA took an average of 417 days
to approve the products, while the FDA, on average, required an additional 35 days."

http://csdd.tufts.edu/_documents/www/Doc_309_12_892.pdf


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