The US FDA has granted approval of IMPAX Laboratories' ANDA for a generic version of Colestid 5 g packet and 5 g scoopful. Pfizer markets the 5 g packet and the 5 g scoopful 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.
"Approval of this ANDA, the first generic version of Colestid, validates our strategy to develop and market niche generic drugs for which there is a limited competitive environment," said Larry Hsu, IMPAX's president. "This is our second ANDA approval this year," he added.
IMPAX Laboratories is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its global pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division.