Dr. Reddy’s Laboratories (NYSE: RDY) announced today that is has launched Lamotrigine Extended-Release Tablets (25 mg, 50 mg, 100 mg, 200 mg, 300 mg) a therapeutic equivalent generic version of Lamictal ® XR (lamotrigine) in the US market on June 25, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Lamotrigine XR tablets. The Lamictal ® XR brand and generic had combined U.S. sales of approximately $300.5 Million MAT for the most recent twelve months ending in April 2013 according to IMS Health*. Dr. Reddy’s Lamotrigine XR Tablets 25 mg, 50 mg, 100 mg, 200 mg, and 300 mg are available as unit of use bottles of 30s.
|WARNING: SERIOUS SKIN RASHES|
|See full prescribing information for complete boxed warning.|
|Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include (5.1):|
|• coadministration with valproate|
|• exceeding recommended initial dose of lamotrigine extended-release tablets|
|• exceeding recommended dose escalation for lamotrigine extended-release tablets|
|Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine extended-release tablets should be discontinued at the first sign of rash, unless the rash is clearly not drug related. (5.1)|