Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

MISSION PHARMACAL's URINARY ALKALINIZER IS "APPROVABLE"

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS008805

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel