FDA OrangeBook code

U-2070

DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY