5th Circuit Holds Generic Drugmakers Not Required To Change Label

Mealey's (May 28, 2024, 2:28 PM EDT) -- NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on May 24 found that three generic drug manufacturers did not have newly acquired risk information that could have been added to the label of a chemotherapy drug that allegedly caused permanent chemotherapy-induced alopecia (PCIA) in cancer patients with the possible exception of one abstract presented at a December 2013 conference and remanded the case to the trial court to consider the incidence rate of minimal cases in that study....