Not all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to four companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.
These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.
New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.