IMPAX Laboratories, Inc. (IPXL) Files Motion To Intervene As Defendant In Litigation Related To Generic Allegra-D
10/19/2005 5:12:52 PM
HAYWARD, Calif.--(BUSINESS WIRE)--Feb. 28, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that it has filed a motion in the United States District Court for the District of Columbia to intervene as a defendant in a lawsuit by Barr Laboratories, Inc. against the United States Food and Drug Administration (FDA). Earlier this month, Barr Laboratories, a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:BRL), brought suit against the FDA in an attempt to prevent the agency from granting final approval to IMPAX's Abbreviated New Drug Application (ANDA) for its Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, a generic version of Allegra-D(R). IMPAX was granted tentative approval of the generic product in February 2004. Aventis Pharmaceuticals markets Allegra-D for the treatment of the symptoms associated with seasonal allergic rhinitis. According to NDCHealth, U.S. sales of Allegra-D were approximately $425 million in the 12 months ended December 31, 2004.