Hi-Tech (HITK) Gets FDA Approval for Generica Keppra ANDA
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Hi-Tech Pharmacal Co., Inc. (Nasdaq: HITK), reports that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Levetiracetam oral solution 100mg/mL, the generic for UCB Pharma’s Keppra oral solution which had combined brand and generic sales of $62 million for the 12 months ended December 2011 according to IMS sales data. The product is used to treat partial onset seizures in people 16 years of age and older with epilepsy. Hi-Tech plans to launch the product by May 2012.
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