Today was a tough day for my employer. News of two FDA Not Approvable letters came out; the first about our Schering Plough Joint Venture product combining Singulair and Claritin and the second about our extended release Niacin table called Cordaptive.
I’m surprised by both and am curious considering no reasons have been identified yet that I’ve read for the rejections. Plus, as a user of both Singulair and Claritin, it would be a huge boon to only have to purchase and take one set of pills, not two. Hopefully the JV will get the FDA to re-evaluate.