The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.''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.
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Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance ...
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81 FR 4916
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“Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability,” thefederalregister.org (January 28, 2016), https://thefederalregister.org/documents/2016-01683/bioequivalence-recommendations-for-lamotrigine-draft-guidance-for-industry-availability.