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FDA approval for generic Lidocaine/Prilocaine Anesthetic Cream

AMITYVILLE, N.Y., September 29, 2003 -- Hi-Tech Pharmacal Co. announced that the company has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Lidocaine 2.5% and Prilocaine 2.5% cream.

Hi-Tech's Lidocaine/Prilocaine cream is the generic equivalent of AstraZeneca's Emla cream, indicated as a topical anesthetic for local analgesia. The Lidocaine/Prilocaine cream is a prescription product used in hospitals and in doctors' offices for local analgesia in cases of dermatological procedures in adults and children.

Hi-Tech will offer its Lidocaine/Prilocaine cream with a child resistant closure (CRC), required for retail pharmacy distribution by the Poison Prevention Packaging Act of the U.S. Consumer Products Safety Commission (CPSC).

Source: Hi-Tech Pharmacal

Posted: September 2003