By Tess Stynes
Actavis Inc. (ACT) said it received U.S. Food and Drug
Administration approval for its generic version of GlaxoSmithKline
PLC's (GSK, GSK.LN) Lamictal drug for epilepsy and bipolar disorder
and plans to launch its tablet--called
Lamotrigine--immediately.
Actavis said as the first applicant to submit a substantially
completed application to the FDA, it may be eligible for 180 days
of generic market-exclusivity, though the regulator won't make a
decision on that unless another applicant becomes eligible within
180 days after Lamotrigine's commercial launch.
The company cited IMS Health data indicating U.S. Lamictal sales
reached about $51 million during the 12 months ended May 31.
Actavis in May agreed to acquire Warner Chilcott PLC (WCRX) for
about $5 billion in an all-stock deal aimed at enlarging Actavis's
portfolio of specialty pharmaceutical brands--and shrinking its tax
burden.
Actavis shares were up 34 cents at $125.52 in light after-hours
trading. Glaxo's American depositary shares were unchanged at
$52.62.
Write to Tess Stynes at Tess.Stynes@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires