Lupin Gets Final US FDA Approval For Lamotrigine Tablets
June 04 2010 - 2:21AM
Dow Jones News
Indian generic drug maker Lupin Ltd. (500257.BY) said Friday its
U.S. unit has received final approval from the U.S Food and Drug
Administration to make and sell Lamotrigine tablets.
The approval is for tablets in strengths of 25 milligrams, 100
mg, 150 mg and 200 mg, the company said in a filing to the Bombay
Stock Exchange.
Lamotrigine is the generic form of GlaxoSmithKline's (GSK)
Lamictal tablets and is used for the treatment of epilepsy and
bipolar disorder.
Lamotrigine tablets have annual U.S. sales of about $452
million, the company said, citing data from IMS Health market
research.
-By Gurdev Singh Virk, Dow Jones Newswires; 91 22 2288 4212;
gurdev.singh@dowjones.com
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