Orchid Pharmaceuticals, Glenmark Pharmaceuticals, Lupin and Aurobindo Pharmaceuticals have all received US FDA approval for their abbreviated new drug applications (ANDAs) for Levetiracetam tablets, according to individual statements filed with the Bombay Stock Exchange on Friday.
Aurobindo Pharma in addition has also received approval for an oral solution of Levetiracetam. Levetiracetam is used in the treatment of partial onset seizures in adults and children.
The drug had recorded sales of $1.1 billion for the year ending September 2008, according to IMS, a US-based research and consultancy body that periodically comes out with sales figures of various drugs. Sales of Levetiracetam grew 36% from the previous year, the IMS said, adding that it also ranked within the top five anti-epileptic tablets.
The approval will take Orchid's FDA approvals to 30; Glenmark's total approvals stands at almost 40, while Aurobindo has 89.