Glenmark Generics Inc., USA(GGI) has been granted final Abbreviated New Drug Application (ANDA) approval by the US FDA for lithium carbonate 300 mg extended-release tablets. GGI will commence marketing and distribution of the product immediately. Glenmark anticipates a successful launch as they will be one of the two generic players in this market.
Lithium carbonate 300mg extended-release tablets are Glenmarkâs generic version of Noven Therapeutics Lithobid which is indicated in the treatment of manic episodes of bipolar disorder. Total sales achieved in the US for the 12 month period ending September 2010 were US $ 21 million, according to IMS Health.
Glenmark is currently authorised to distribute 66 products in the US as the company maintains an aggressive ANDA filing strategy and continues to rely on the strength of its internal pipeline projects as well as continuing to explore partnerships to augment the breadth of their existing portfolio.
GGL is a subsidiary of Glenmark Pharmaceuticals Limited (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. It primarily sells its FDF products in the US and the EU, as well as its oncology FDF products in South America.