Tag: bioequivalence

FDA Authorization of Generics: Legal Basis and Approval Process

FDA Authorization of Generics: Legal Basis and Approval Process

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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Clinical Outcomes After NTI Generic Switches: What Studies Show

Clinical Outcomes After NTI Generic Switches: What Studies Show

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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