HAYWARD, Calif., Jan 28, 2004 (BUSINESS WIRE) -- IMPAX
Laboratories, Inc. (NASDAQ:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted final approval to the Company's
Abbreviated New Drug Application (ANDA) for its generic version of
Wellbutrin(R) SR (Bupropion Hydrochloride) 100 mg Controlled Release
Tablets and has granted tentative approval to the Company's generic
version of Wellbutrin SR 150 mg Controlled Release Tablets.
GlaxoSmithKline (NYSE:GSK) markets Wellbutrin SR for the treatment of
depression. According to NDCHealth, U.S. sales of these dosage forms
of Wellbutrin SR Tablets were approximately $1.6 billion in the 12
months ended November 30, 2003.
Conversion of the 150 mg strength tentative approval to final
approval is contingent upon any generic marketing exclusivity. Final
approval also is dependent upon FDA's evaluation of any new
information subsequent to the tentative approval.
"We are pleased to have received these important approvals and
continue to work diligently with our partners, Teva (NASDAQ:TEVA) and
Andrx (NASDAQ:ADRX), toward the final approval of the 150 mg
strength," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President.
IMPAX currently has 20 applications pending at the FDA, including
five tentatively approved, which address over $7 billion in U.S.
market sales for the 12 months ended November 30, 2003. Fifteen of
these filings were made under Paragraph IV of the Hatch-Waxman
Amendments.
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:
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, 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.
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-289-2220 Ext. 1771
Larry Hsu, Ph.D., 510-476-2000 Ext. 1111
Cornel C. Spiegler, 215-289-2220 Ext. 1706
www.impaxlabs.com
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
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