Par Pharmaceutical Companies' operating subsidiary,  Par Pharmaceutical, Inc. has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg and 300 mg extended-release (ER) tablets.

Lamotrigine ER is the generic version of GlaxoSmithKline’s Lamictal XR and is indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients = 13 years of age.

Par has begun shipping all strengths of the product. According to IMS Health data, annual US sales of Lamictal XR are approximately $265 million.

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic-epidermal necrolysis, and/or rash-related death, have been caused by lamotrigine. The rate of serious rash is greater in paediatric patients than in adults. Lamotrigine ER should be discontinued at the first sign of rash unless the rash is clearly not drug-related.

Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.