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Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.''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.