Biocraft sucralfate bioequivalence summary lacks fair balance -- DDMAC letter.
Executive Summary
BIOCRAFT SUCRALFATE BIOEQUIVALENCE SUMMARY LACKS ADVERSE EFFECT INFO, FDA maintains in a Dec. 19 letter to the company. A summary comparing the Biocraft product to the Hoechst Marion Roussel's Carafate (sucralfate) "fails to present a fair balance between information relating to the side effects and contraindications and information relating to the effectiveness of the drug," the letter from FDA's Division of Drug Marketing, Advertising & Communications states.