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news.Hi-Tech Pharmacal has received the FDA approval for its abbreviated new drug application (ANDA) for Levetiracetam oral solution 100mg/mL, the generic for UCB Pharma's Keppra oral solution.
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Levetiracetam oral solution is used to treat partial onset seizures in people 16 years of age and older with epilepsy.
The company expects to launch the product by May 2012.
Hi-Tech currently has 14 products awaiting approval at the FDA, targeting brand and generic sales of over $1.5bn.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products.