Impax gets FDA approval for generic version of Colestid

By Elaine Rigoli

Tampa, Fla., May 3 - Impax Laboratories, Inc. said the Food and Drug Administration approved the company's abbreviated New Drug Application for a generic version of Colestid 5 g packet and 5 g scoopful.

Pharmacia and Upjohn Co. (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.

Total brand sales of unflavored Colestid in the United States were $7.5 million for the 12 months ended March 31, according to Wolters Kluwer Health.

Impax said its global pharmaceuticals division intends to begin marketing this product soon.

Impax, based in Hayward, Calif., 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.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.