kareem
29-08-2003, Fri 9:15 PM
August 29, 2003 13:15
Atrix Receives FDA Approval for First Generic Topical, Deficiency on a Second
FORT COLLINS, Colo., Aug. 29 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. (Nasdaq: ATRX) announced today the company 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 Receives FDA Approval for First Generic Topical, Deficiency on a Second
FORT COLLINS, Colo., Aug. 29 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. (Nasdaq: ATRX) announced today the company 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