Lupin Gets US FDA Approval for Lamotrigine Tablets
MUMBAI -(Dow Jones)- 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.
June 16, 2010