Mylan receives final FDA approvals for generic Lamictal tablets

Jan 29 2009

Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. 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(R) Tablets. This product had annual U.S. sales of approximately $2.5 billion for the 12 months ending Sept. 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(R) CD Tablets. This product had annual U.S. sales of approximately $91 million for the 12 months ending Sept. 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.