ABBOTT ZYFLO (ZILEUTON) LABELING RECOMMENDS AT LEAST SEVEN LIVER MONITORING TESTS IN FIRST YEAR ON ASTHMA THERAPY; LEUKOTRIENE ANTAGONIST CLEARS AGENCY DEC. 9
Abbott's leukotriene antagonist Zyflo labeling recommends a minimum of seven liver monitoring tests during the first year of therapy. Labeling advises that "hepatic transaminases be evaluated at initiation of, and during therapy with, Zyflo" and that serum ALT -- the most sensitive indicator of liver injury -- "be monitored before treatment begins, once-a-month for the first three months, every two to three months for the remainder of the first year, and periodically thereafter." FDA approved Zyflo (zileuton) for asthma on Dec. 9.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth