Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar
As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.
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US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.
US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.
Patient instructions for use of Mylan’s fluticasone/salmeterol generic are noticeably different from GSK’s reference listed drug but fall within the ‘different manufacturers’ exception to the ‘same labeling’ requirement.