BRIEF-FDA Issues Class-Wide Labeling Changes For Testosterone Products
ReutersFeb 28, 2025 8:01 PM
Feb 28 (Reuters) - FDA:
FDA ISSUES CLASS-WIDE LABELING CHANGES FOR TESTOSTERONE PRODUCTS
FDA: RECOMMENDING CHANGES TO CURRENT LABELING LANGUAGE TO INCLUDE ADDING RESULTS OF TRAVERSE TRIAL TO ALL TESTOSTERONE PRODUCTS
FDA: RECOMMENDS REMOVING LANGUAGE FROM BOXED WARNING RELATED TO INCREASED RISK OF ADVERSE CARDIOVASCULAR OUTCOMES FOR ALL TESTOSTERONE PRODUCTS
FDA: RECOMMENDS TO ADD WARNING ABOUT INCREASED BLOOD PRESSURE FOR TESTOSTERONE PRODUCTS WHICH DO NOT HAVE SUCH WARNING IN THEIR LABELING
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