University of Iowa

Approvable Recommendation

In a letter from the Kansas City District Office of the FDA, UIP received notice that based on the results of our most recent GMP inspection (November of 2011) the Kansas City District has recommended that a client’s NDA is approvable. The product is a non-sterile topical that is intended for the treatment of a rare form of cancer. This is the second successful PAI for UIP since 2009. The UIP manufacturing facility received no 483 items as a result of this inspection. UIP looks forward to the client obtaining approval of their NDA and starting commercial production operations for this product.