IMPAX WINS APPROVAL, MARKET EXCLUSIVITY FOR GENERIC COLESTID

Impax Laboratories announced that the FDA has approved the company's abbreviated new drug application (ANDA) for a generic version of Colestid Tablets (colestipol hydrochloride), 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 market the brand drug as adjunctive therapy to diet for the reduction of elevated serum total and LDL cholesterol in patients with primary hypercholesterolemia (elevated LDL cholesterol) who do not respond adequately to diet. Total brand sales of 1-gram Colestid in the U.S. were $20 million for the 12 months ending in August, Impax said, citing Wolters Kluwer Health.

This is Impax's third ANDA approval this year. The company markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division.