Learn how the FDA approves generic drugs under the Hatch-Waxman Act, including the ANDA process, bioequivalence requirements, patent challenges, and how this system keeps prescription costs low for millions of Americans.
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Studies show that switching to generic NTI drugs like warfarin, phenytoin, and cyclosporine can lead to dangerous fluctuations in blood levels. While some patients adapt safely, others face seizures, rejection, or bleeding. Monitoring and caution are critical.
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