Intellipharmaceutics International Inc. (IPCI)

[dtstx]

Also good news on the ANDA front.

The FDA notified Wyeth as the NDA holder of Effexor and Pristiq in Sept., to update new safety information in regards to serotonin warnings and precautions. They responded in October and FDA approval just came out 6 days ago. Both of these drugs are affected by the same update change.

The same day 1 NDA and 11 ANDA's, which have made similar changes, were approved as well in regards to Effexor. A few more companies followed with Pristiq updates, all addressing the same issue.

The 12 addressing Effexor all had initial approval dates from 2006-2010 only. IPCI's filing was accepted May, 2010. I can't help but feel this one is close at hand.

Our Pristiq partner, Mallinckodt, I'm sure is noticing and it would be great if they were interested in Effexor XR as well since it isn't part of their portfolio yet.