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news.Mylan, a generic pharmaceutical company, has announced that its subsidiaries Mylan Pharmaceuticals and Genpharm have received final approvals from the FDA for their abbreviated new drug applications for lamotrigine tablets.
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Genpharm has also received final FDA approval for its abbreviated new drug application (ANDA) for a separate lamotrigine product, lamotrigine tablets chewable dispersible (CD).
Mylan Pharmaceuticals’s and Genpharm’s ANDAs were approved for the 25mg, 100mg, 150mg and 200mg strengths of the generic version of GlaxoSmithKline’s Lamictal tablets. Genpharm’s ANDA was approved for the 5mg and 25mg strengths of the generic version of GlaxoSmithKline’s Lamictal CD tablets.
These products are used for the treatment of epilepsy and for maintenance treatment of bipolar I disorder. Mylan will distribute both products immediately and under the Mylan Pharmaceuticals label.