Wednesday, December 12, 2007

Mylan Announces Tentative FDA Approval for Lamotrigine Tablets

PITTSBURGH, December 12, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets, 25 mg, 100 mg, 150 mg and 200 mg.

Lamotrigine Tablets are the generic version of GlaxoSmithKline's Lamictal(R) Tablets, which had U.S. sales of approximately $1.97 million for the 12 months ending Sept. 30, 2007.

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