Healthcare Industry News: Impax Laboratories
News Release - October 26, 2006
IMPAX Receives FDA Approval for Generic Version of Colestid(R) TabletsCompany Awarded 180-day Market Exclusivity
HAYWARD, Calif.--(HSMN NewsFeed)--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.
"This is our third ANDA approval this year," commented Larry Hsu, Ph.D., IMPAX's President and Chief Executive Officer. "We are looking forward to our Global Pharmaceuticals division marketing our generic Colestid Tablets very shortly."
About Impax Laboratories, Inc.
Impax Laboratories, Inc. 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 markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for each of the first two quarters of 2006, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Source: IMPAX Laboratories
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