Glenmark Generics Inc (GGI) the US-subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the US FDA for lamotrigine 25, 100, 150, and 200 mg tablets, their generic version of GlaxoSmithKline’s Lamictal.
Lamotrigine is an antiepileptic drug indicated for epilepsy and bipolar disorder. According to IMS Health sales data for the 12 month period ending December 2011, lamotrigine tablets garnered annual sales of $62 million.
Glenmark’s current portfolio consists of 80 products authorised for distribution in the US marketplace and 38 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
EP News Bureau – Mumbai