Wednesday, March 02, 2016 11:51:02 AM
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf
Also there were (4) approved ANDA Pristiq companies in June. They were all approved the same day. They were filed early in 2012. Ours in September, 2012. They all had 180 day exclusivity to market which just recently expired thereby allowing another company approval 2-16-16. That is now out of the way so smooth sailing for us once approved and funded.
The significance is both drugs are made by Wyeth/Pfizer. Desvenlafaxine is a derivative of Venlafaxine which apparently the FDA is focused upon.
On another note an approval for a Protonix ANDA on 1-26-16 filed well after ours.
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