DETROIT Caraco Pharmaceuticals has received tentative approval from the Food and Drug Administration for its application for lamotrigine tablets, the generic version for the anti-seizure and bipolar disorder medication Lamictal.
The company expects final approval before the patent expiration of the brand, which is scheduled for Jan. 22, 2009. The drug will be available in all forms of the brand, which include: 25 mg, 100 mg, 150 mg and 250 mg.
“We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent in January 2009, which will allow Caraco to market the product.” Daniel Movens, Caraco’s chief executive officer, said. “We feel that generic Lamictal will be a positive addition to our portfolio by expanding our product offerings.”
According to IMS data, the drug had sales in the U.S. of about $1.89 billion for the year ended Sept. 30, 2007.