Healthcare Industry News: Evoke
News Release - May 29, 2007
IMPAX Receives Final FDA Approval for Generic Xanax(R) XR Extended Release Tablets
Global Pharmaceuticals Division to LaunchHAYWARD, Calif.--(HSMN NewsFeed)--IMPAX Laboratories, Inc. (OTC:IPXL ) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Xanax® XR, (Alprazolam) 0.5 mg, 1 mg, 2 mg and 3 mg Extended-release Tablets. Pharmacia and Upjohn markets Xanax XR for the management of anxiety disorder or the short-term relief of symptoms of anxiety. IMPAX' Global Pharmaceuticals division plans to launch the product soon.
U.S. sales of the combined branded and generic 0.5 mg, 1 mg, 2 mg and 3 mg dosage forms were approximately $51 million in the 12 months ended March 2007, according to Wolters Kluwer Health.
"This is our third FDA approval this year and we are looking forward to adding our generic Xanax XR to the growing portfolio of our marketed products," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.
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 and suspension of trading in IMPAX's stock, the SEC proceeding to determine whether to suspend or rEvoke the registration of IMPAX's securities under section 12 of the Securities Exchange Act, IMPAX's delay in filing its periodic reports subsequent to its Form 10-Q for the third quarter of 2004, 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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