Executive Summary

MISSION PHARMACAL's URINARY ALKALINIZER IS "APPROVABLE" for use in the prevention of uric acid kidney stones, calcium oxalate kidney stones, and calcium phosphate kidney stones. The product will be indicated both for the prevention of stones in patients with a urinary condition likely to cause such stones and for the prevention of stone reformation in patients who have previously had stones. The product was given orphan drug status by FDA during 1984. FDA designated the drug "approvable" on July 26. Urocit-K will be Mission's third orphan approval in three years. FDA approved two other kidney products, Calcibind and Lithostat, in 1982 and 1983, respectively. Both Urocit-K and Calcibind were developed by University of Texas' Dr. Charles Pak. Mission said it expects FDA to approve the final labeling of the drug within the next few weeks and has started booking orders. The firm said that the price of the Urocit-K gotassium citrate) will be $42.50 plus a $2.50 handling charge for six bottles of 100 tabs. The proposed dosage recommendation is 4 tabs three times a day.