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Zdrowie i gospodarka · 28.01.2016

Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets.

Source: Federal Register — Food and Drug AdministrationOpen original release →