HAYWARD, Calif.--(BUSINESS WIRE)--March 7, 2006--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application for Vadova(R) (carbidopa/levodopa) tablets. The letter cites several deficiencies in the application including observations resulting from an FDA inspection of the contract laboratory employed by IMPAX to perform bioequivalence studies. IMPAX is seeking a meeting with the FDA to review the comments in detail. The Company is unable to predict whether, and if so when Vadova might be available for commercial launch. Commenting on this news, Dr. Larry Hsu, IMPAX's president stated, "We are disappointed with this development and we will work diligently with the FDA and the contract laboratory to provide the additional data required for approval as fast as prudently possible. We followed the study design described in our Investigational New Drug application and we believe the results obtained not only present a valuable product for the patient but are within the regulatory requirements."
