FDA approves new version of GlaxoSmithKline drug Lamictal

The U.S. Food and Drug Administration has approved a pill version of the GlaxoSmithKline drug Lamictal that disintegrates on the tongue, the world’s second largest drug maker said Monday.

Lamictal, which treats epilepsy and bipolar disorder, was a blockbuster drug for GSK (NYSE: GSK) before generic competition was introduced in the U.S. market last year. Worldwide sales of Lamictal were down 61 percent, to $207 million, in the first quarter.

Blockbuster drugs have annual sales of more than $1 billion.

England-based GSK, which bases its U.S. operations in Research Triangle Park. is touting its new version of Lamictal as a better option for epilepsy and bipolar patients that have trouble swallowing regular pills.

Milan, Italy-based Eurand N.V. (Nasdaq: EURX) partnered with GSK in developing the disintegrating Lamical tablet and has a patent pending on the new formulation.

A GlaxoSmithKline spokeswoman, citing company policy, declined to say how much the new version of Lamictal might generate in sales.

The original version of Lamictal was developed more than a decade ago by Burroughs Wellcome, an RTP-based company that became GlaxoSmithKline after a series of mergers.

GSK is one of the largest employers in the Raleigh-Durham area. The company employs 4,000 people in RTP and about 1,000 more at a manufacturing facility in the eastern Wake County town of Zebulon.

Source : www.bizjournals.com