Hi-Tech Pharmacal Receives Final Approval for Levetiracetam Oral Solution

Hi-Tech Pharmacal Co

announced today that the US Food and Drug Administration, granted final approval for the Company's Abbreviated New Drug Application, 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. Hi-Tech currently has 14 products awaiting approval at the FDA, targeting brand and generic sales of over $1.5 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $3 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.