U.S. Food and Drug Administration today issued tentative approval for Mylan Pharmaceuticals Inc’s Lamotrigine tablets.
Lamotrigine is the generic version of GlaxoSmithKline's Lamictal tablets which is an anticonvulsant drug used to treat partial seizures associated with epilepsy. It is 
also used as a mood stabilizer and was the first drug since lithium granted FDA approval for the maintenance treatment of bipolar type I disorder. It was granted FDA approval for the treatment of epilepsy in 1994 and bipolar I disorder in 2003.
Black box warnings include Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. More common side effects include headaches, dizziness, insomnia, acne, vivid dreams, body aches, fatigue, memory and cognitive problems, irritability, changes in libido, nausea and others.
Teva Pharmaceuticals also sells generic Lamotrigine but only in 5 mg and 25 mg chewable forms. Mylan has received approval to distribute 25 mg, 100 mg, 150 mg and 200 mg. tablets.
[Source: PRNewsWire]
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