HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Colestid® Tablets (Colestipol Hydrochloride Tablets) 1 gram. The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product under Paragraph IV of the Hatch-Waxman amendments. Pharmacia and Upjohn Company (Pfizer) markets the 1 gram Tablet as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Total brand sales of Colestid® Tablets 1 gram in the U.S. were $20 million for the 12 months ended August 31, 2006, according to Wolters Kluwer Health.
