Four Indian pharma majors, Aurobindo Pharma, Orchid Chemicals and Pharmaceuticals, Lupin Ltd and Glenmark Pharmaceuticals have received the US FDA approval for Abbreviated New Drug Application (ANDA) for marketing and distribution of Levetiracetam tablets of 250 mg, 500 mg and 750 mg range in the US market.
Aurobind Pharma has received final approval for Levetiracetam tablets of 1000 mg and oral solution 100mg/ml also. With this approval Aurobindo now has a total of 89 ANDA approvals from US FDA.
The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) has received approval from the US FDA for its ANDA for Levetiracetam tablets, 250 mg, 500 mg and 750 mg.
Lupin's subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received the final approval for Levetiracetam tablets 250mg, 500mg, 750 mg and 1000 mg. The company has commenced commercial shipments of the product.
Glenmark Generics Inc. (GGI), USA, the subsidiary of Glenmark Generics Ltd, initiated shipping immediately upon final ANDA approval for Levetiracetam tablets through its longstanding partnership with Invagen Pharmaceuticals Inc. Based on the terms of this collaboration Glenmark will exclusively market and distribute the product while Invagen will be responsible for the manufacture and supply. With this launch, Glenmark will now have 38 generic products authorized for distribution in the US market.
Levtiracetam tablets are indicated as an adjunctive therapy for the treatment of partial onset seizures in adults and children (above four years) with epilepsy. According to IMS Health data for the 12 month period ending September 2008, Levetiracetam tablets recorded sales of USD 1.1 billion, growing at a rate of 36 per cent corresponding period for the previous year. For the 12 month period ending September 2008, Levetiracetam is ranked within the top five oral solid anti-epileptic (N3A) products.
Terrance Coughlin, chief executive officer, Glenmark Generics, stated, "This day one approval has tremendous significance for Glenmark as we would be one of the first few companies to launch the generic version of UCB Inc's product Keppra and we have already commenced distribution. From the beginning we have focused on building a diversified pipeline which would enable us grow at a faster rate."
The Glenmark's US subsidiary currently has over 40 ANDAs filed with the US FDA pending approval. 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.