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IMPAX Receives FDA Non-Approvable Letter for Vadova; Company to Request Meeting With FDA |
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07 Mar 2006 |
HAYWARD, CA, USA | Mar 07, 2006 | IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application for Vadova(R) (carbidopa/levodopa) tablets. The letter cites several deficiencies in the application including observations resulting from an FDA inspection of the contract laboratory employed by IMPAX to perform bioequivalence studies. IMPAX is seeking a meeting with the FDA to review the comments in detail. The Company is unable to predict whether, and if so when Vadova might be available for commercial launch. Commenting on this news, Dr. Larry Hsu, IMPAX's president stated, "We are disappointed with this development and we will work diligently with the FDA and the contract laboratory to provide the additional data required for approval as fast as prudently possible. We followed the study design described in our Investigational New Drug application and we believe the results obtained not only present a valuable product for the patient but are within the regulatory requirements."
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 intends to market 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:
o 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 and 2005 Form 10-K's and its Form 10-Q's for the first three quarters of 2005, 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, Inc. |
