Mylan Inc. announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the US Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for lamotrigine tablets. Genpharm also received final FDA approval for its ANDA for a separate lamotrigine product, lamotrigine tablets chewable dispersible (CD).
Mylan Pharmaceuticals' and Genpharm's ANDAs were approved for the 25 mg, 100 mg, 150 mg and 200 mg strengths of the generic version of GlaxoSmithKline's Lamictal tablets. This product had annual U.S. sales of approximately $2.5 billion for the 12 months ending September 30, 2008, for the same strengths according to IMS Health.
Genpharm's ANDA was approved for the 5 mg and 25 mg strengths of the generic version of GlaxoSmithKline's Lamictal CD tablets. This product had annual U.S. sales of approximately $91 million for the 12 months ending September 30, 2008, for the same strengths according to IMS Health.
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.
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world.