Atrix Laboratories Inc has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lidocaine/prilocaine cream.
Atrix's product is the AB-rated generic to EMLA(R) Anesthetic Cream (lidocaine 2.5 percent and prilocaine 2.5 percent), which is marketed by AstraZeneca Pharmaceuticals LP. EMLA is indicated for use as a topical local anesthetic. Branded retail pharmacy sales of EMLA were more than $35 million for the year ended December 2002. Additionally, EMLA is sold to hospitals and direct to physicians. This newly approved product will be marketed by Geneva Pharmaceuticals, an affiliate of Novartis AG. Additionally, this new generic version of EMLA will be offered with a child-resistant closure (CRC), required for retail pharmacy distribution of this product to comply with the Poison Prevention Packaging Act of the U.S. Consumer Products Safety Commission (CPSC).
Atrix also is in receipt of an action letter from the FDA explaining why another generic dermatology product was not approved. The company is currently reviewing the letter to determine what actions will be taken in regard to this FDA letter.
David R. Bethune, Atrix's chairman and chief executive officer commented, "Obviously we are disappointed that both of these first two generic topical ANDAs that were submitted to the FDA were not approved together. These were difficult products to formulate and develop but we believe we followed the guidelines provided by the FDA in each submission."