HAYWARD, Calif.--(BUSINESS WIRE)--April 17, 2008--IMPAX
Laboratories, Inc. (OTC: IPXL) reports that the U.S. Food and Drug
Administration (FDA) has issued its report concerning the Therapeutic
Equivalence of Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg
and found that our generic buproprion extended-release tablets,
marketed as Budeprion XL 300 milligram by our partner Teva
Pharmaceutical USA, is a safe and effective choice for consumers in
treating depression. In addition, it has been shown to meet all
requirements for approval, including bioequivalence to the branded
drug, Wellbutrin XL(R) 300 milligram.
"We are committed to providing patients with high quality, lower
cost alternatives to branded pharmaceutical products. Recent patient
concerns about the bioequivalence of our buproprion product to
Wellbutrin XL 300 mg can now be put to rest," commented Larry Hsu,
Ph.D., president and chief executive officer of IMPAX Laboratories.
"IMPAX is pleased that the study confirms the confidence we have had
in our product all along."
The full FDA Report can be viewed at:
www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm
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 2004 Form 10-K,
its Form 10-Q for each of the first three quarters of 2005, 2006, and
2007 and its Form 10-K for 2005, 2006 and 2007, the actual time that
will be required to complete the filing of IMPAX's delinquent periodic
reports, 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
Mark Donohue, Sr. Director, IR
215-933-3526
or
Investor Relations Contacts:
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.