Approvable Recommendation

In a letter dated June 15th from the Kansas City District Office of the FDA, UIP received notice that based on the results of our most recent GMP inspection (March and April of 2009) the Kansas City District has recommended that a client’s ANDA is approvable.  In a separate communication dated July 2nd from the Kansas City District Office of the FDA, UIP received the establishment inspection report (EIR) for our most recent GMP inspection, indicating that the FDA has closed this inspection and found UIP responses to the auditor’s findings acceptable.