FDA Approval Activities for this Drug…

Lamictal (lamotrigine) Tablets, SmithKline Beecham NDA 20-241/S-018 4/4/03 4/18/03 Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, GlaxoSmithKline NDA 20-241/S-017 & 20-764/S-011 6/20/03 7/6/03 7/8/03 Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, 25, 100, 150 and 200mg & 2.5 and 25 mg, Glaxo Wellcome NDA 20-241/S-008 & 20-764/S-002 1/17/03 1/23/03 Lamictal (lamotrigine) Chewable Dispersible Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-764 8/24/98 8/24/98 8/24/98 5/20/99 Lamictal Indications: This application provides bioequivalency data to support a new dosage form of lamotrigine, and clinical data to support a new indication for the use of lamotrigine, as compared to the already approved Lamictal Tablet. Specifically, the new indication is for the use of lamotrigine for adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients. Lamictal (lamotrigine) Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-241/ S-002: 8/24/98 8/24/98 8/24/98 5/20/99 Lamictal Indications: This application (NDA 20-241/S-002), an efficacy supplement, incorporates by reference the clinical data contained in the Lamictal CD Chewable Tablet application (NDA 20-764) so that the approved compressed tablet formulation can gain the new indication, as well. This cross-reference also allows for the development of one label for both lamotrigine products. Lamictal (lamotrigine) Tablets& Lamictal (lamotrigine) Chewable Dispersible Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-241/S-003 & NDA 20-764/S-001 12/14/98 12/15/98 12/15/98 6/30/99 Lamictal Indications: These efficacy supplements provide for the use of Lamictal as conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug (EIAED). Lamictal Tablets and Lamictal Chewable Dispersible Tablets , Glaxo Wellcome NDA 20-241/S-011 & NDA 20-764/S-005: 5/25/01 5/29/01 Lamictal Indication: Application provides for: clinical data in support of a labeling revision to update the Geriatric Use subsection of the Lamictal package insert. Lamictal (lamotrigine) Tablets, SmithKline Beecham NDA 20-241/S-018 4/4/03 4/18/03 Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, GlaxoSmithKline NDA 20-241/S-017 & 20-764/S-011 6/20/03 7/6/03 7/8/03 Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, 25, 100, 150 and 200mg & 2.5 and 25 mg, Glaxo Wellcome NDA 20-241/S-008 & 20-764/S-002 1/17/03 1/23/03 Lamictal (lamotrigine) Chewable Dispersible Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-764 8/24/98 8/24/98 8/24/98 5/20/99 Lamictal Indications: This application provides bioequivalency data to support a new dosage form of lamotrigine, and clinical data to support a new indication for the use of lamotrigine, as compared to the already approved Lamictal Tablet. Specifically, the new indication is for the use of lamotrigine for adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients. Lamictal (lamotrigine) Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-241/ S-002: 8/24/98 8/24/98 8/24/98 5/20/99 Lamictal Indications: This application (NDA 20-241/S-002), an efficacy supplement, incorporates by reference the clinical data contained in the Lamictal CD Chewable Tablet application (NDA 20-764) so that the approved compressed tablet formulation can gain the new indication, as well. This cross-reference also allows for the development of one label for both lamotrigine products. Lamictal (lamotrigine) Tablets& Lamictal (lamotrigine) Chewable Dispersible Tablets,Dear Health Professional Letter Glaxo Wellcome NDA 20-241/S-003 & NDA 20-764/S-001 12/14/98 12/15/98 12/15/98 6/30/99 Lamictal Indications: These efficacy supplements provide for the use of Lamictal as conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug (EIAED). Lamictal Tablets and Lamictal Chewable Dispersible Tablets , Glaxo Wellcome NDA 20-241/S-011 & NDA 20-764/S-005: 5/25/01 5/29/01 Lamictal Indication: Application provides for: clinical data in support of a labeling revision to update the Geriatric Use subsection of the Lamictal package insert. Lamictal (lamotrigine) Tablets & Chewable Dispersible Tablets, GlaxoSmithKline

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