Mylan wins tentative U.S. OK for generic Lamictal
CHICAGO |
CHICAGO (Reuters) - Mylan Inc MYL.N said on Wednesday it has received tentative U.S. regulatory approval for Lamotrigine tablets, a generic version of a GlaxoSmithKline (GSK.L) drug for bipolar disorder.
The drug was approved by the U.S. Food and Drug Administration in doses of 25 mg, 100 mg, 150 mg and 200 mg.
Lamotrigine tablets are a generic version of GlaxoSmithKline's Lamictal tablets, which had U.S. sales of $1.97 million (963,913 pounds) for the 12 months ended September 30.
(Reporting by Debra Sherman; Editing by John Wallace)
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