Hi-Tech Pharmacal Receives Final Approval for Lidocaine HCl Jelly, 2%

Hi-Tech Pharmacal Co., Inc. HITK announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for sterile lidocaine HCl jelly, 2%, the generic for APP Pharmaceuticals LLC's Xylocaine®. Lidocaine HCl jelly had sales of $17 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation.