FDA clears way for some generic Lamictal versions

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WASHINGTON, March 2 (Reuters) - The U.S. Food and Drug Administration on Friday cleared the way for cheaper, generic versions of some doses of GlaxoSmithKline Plc's (GSK.L) (GSK.N) seizure drug Lamictal.

The FDA, in a Federal Register notice, said that it could approve alternative versions of the drug in 50 milligram and 250 milligram doses as long as all other legal and regulatory requirements are met.

Shares of the Glaxo were off 1.6 percent, or 90 cents, at $54.97 in morning trade on the New York Stock Exchange.

According to the notice, Glaxo has not marketed Lamictal tablets in those doses, which the FDA considers equivalent to a product withdrawal. The FDA said that the so-called withdrawal was not for safety or effectiveness reasons, thus allowing possible competitors to seek clearance for 50 milligram and 250 milligram doses of the drug.

Lamictal, or lamotrigine, is approved to help treat partial seizures in adults and children as well as bipolar disorder in certain patients.

GlaxoSmithKline markets the drug in other strengths.

The FDA made the decision in response to a citizen's petition from a patent attorney that was filed in June 2005. The FDA notice was posted here .

((Reporting by Susan Heavey, editing by Dave Zimmerman; Reuters Messaging: susan.heavey.reuters.com@reuters.net, Phone: 202-354-5848)) Keywords: GLAXOSMITHKLINE LAMICTAL/

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