Product to Be Launched by Global Pharmaceuticals Division
HAYWARD, Calif., Apr 03, 2007 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) ("IMPAX" or "the Company")
announced today that the U.S. Food and Drug Administration (FDA) has
granted final approval of the Company's Abbreviated New Drug
Applications (ANDA) for Nadolol/Bendroflumethiazide 40mg/5mg and
80mg/5mg, generic of Corzide(R). The Company will begin marketing the
products through its Global Pharmaceuticals division in the near
future.
Corzide, marketed by Monarch Pharmaceuticals, a wholly-owned
subsidiary of King Pharmaceuticals, Inc., for the treatment of
hypertension, had sales of approximately $5.5 million in the 12 months
ended February 28, 2007, according to Wolters Kluwer Health.
"This is our first approval in 2007 and we are very pleased to add
generic Corzide to the growing portfolio of products our Global
Pharmaceuticals division offers to patients," said Larry Hsu, Ph.D.,
President and Chief Executive Officer of IMPAX Laboratories.
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 press 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 management's current
expectations and are subject to 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, the 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.
SOURCE: IMPAX Laboratories, Inc.
Company Contacts:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D., President & CEO
510-476-2000, ext. 1111
or
Arthur A. Koch, Jr., CFO, 215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
[email protected]
or
Bruce Voss, 310-691-7100
[email protected]
www.lhai.com