Glenmark Generics Inc USA, a subsidiary of Glenmark Generics, has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Lamotrigine 25, 100, 150 and 200mg Tables, their generic version of Lamictal by GlaxoSmithKline.
Lamotrigine is an antiepileptic drug indicated for Epilepsy and Bipolar Disorder. The sales for the 12 month period ending December 2011, Lamotrigine Tablets garnered $62 million.
With this, the company's current portfolio consists of 80 generic products authorized for distribution in the US market and 38 ANDA's filed with the USFDA pending approval.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.
