HAYWARD, Calif.--(BUSINESS WIRE)--March 5, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food
and Drug Administration (FDA) has granted final approval to the
Company's Abbreviated New Drug Application (ANDA) for a generic
version of Claritin(R)-D 24-Hour (Loratadine and Pseudoephedrine
Sulfate, 10mg/240mg) Extended Release Tablets. Schering-Plough
Corporation (NYSE:SGP) markets Claritin-D 24-Hour as an
over-the-counter (OTC) drug for the relief of symptoms of seasonal
allergic rhinitis (hay fever). According to NDCHealth, U.S. sales of
Claritin-D 24-Hour were $39 million for the 12 months ended December
31, 2003. The Company is working with its marketing partner toward the
commercial launch of this product.
"This is our third ANDA approval in 2004, and reflects the
strength of both our R&D and regulatory teams," said Larry Hsu, Ph.D.,
IMPAX's President. "We are pleased to add Loratadine and
Pseudoephedrine Sulfate, 10mg/240mg Extended Release Tablets to our
growing portfolio of marketed products."
IMPAX currently has 19 applications pending at the FDA, including
five tentatively approved, which address approximately $6.8 billion in
U.S. branded product sales for the 12 months ended December 31, 2003.
Fourteen 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.
CONTACT: IMPAX Laboratories, Inc.
Barry R. Edwards (CEO), 215-289-2220 Ext. 1771
Larry Hsu, Ph.D. (President), 510-476-2000 Ext. 1111
Cornel C. Spiegler (CFO), 215-289-2220 Ext. 1706
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.