Taro Pharma reported today that it has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg.Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal(R) Tablets. According to industry sources, Lamictal(R) Tablets had annual U.S. sales of approximately $2.6 billion. This product has one orange book listed patent US4602017 which will expire on JAN 22,2009.On February 17, 2005, Teva issued a press release regarding settlement with innovator GSK. As per settlement Teva was granted the exclusive right to manufacture and sell its own generic version of Lamotrigine tablets (25mg, 100 mg, 150 mg, and 200 mg) in the United States with an expected launch date in 2008. As per FDA records TEVA is marketing this drug in USA. Following firms have received tentative approval
1) GENPHARM
2) DR REDDYS LABS LTD
3) ROXANE
4) MYLAN PHARMA
5) ZYDUS PHARMS USA INC
6) CARACO
7) WATSON LABS
8) SANDOZ
9) MATRIX LABS
