IMPAX Laboratories, Inc. Receives Final FDA Approval And First-To-File Status For Generic Version Of Ditropan(R) XL 15 Mg

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan® XL, Extended-release Tablets, 15 mg (Oxybutynin Chloride Extended-release Tablets 15 mg). The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL 15 mg were approximately $58 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.