-Global Pharmaceuticals Division to Launch-
HAYWARD, Calif.--(BUSINESS WIRE)--May 29, 2007--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(R) 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.
CONTACT: IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO
510-476-2000, Ext. 1111
Arthur A. Koch, Jr., Sr. VP & CFO
215-933-0351
www.impaxlabs.com
or
Investor Relations:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.