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# FDA Posts Draft Guide on Lamictal Bioequivalence
- URL: https://www.fdaweb.com/fda-posts-draft-guide-on-lamictal-bioequivalence/
- Published: 2016-01-27T12:00:00.000Z
- Updated: 2026-09-15T02:31:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134586

> FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209231.pdf?ref=fdaweb.com) on lamotrigine bioequivalence recommendations for generic drug sponsors to use when seeking approval for generic copies of GlaxoSmithKline’s seizure drug Lamictal extended-release tablets. The guidance calls for three studies to demonstrate bioequivalence. They are: Fasting study: Single-dose, two-way crossover in vivo for the 200 mg tablet Fed study: Single-dose, two-way crossover in vivo for the 200 mg tablet Fasting study: Single-dose, two-way, crossover in vivo for the the 50 mg tablet