CORRECTING and REPLACING IMPAX Receives FDA Approval for Generic Version of Rimadyl, a Veterinary Product; Fourth Approval in 20
2005年5月3日 - 12:01AM
ビジネスワイヤ(英語)
First graph, first sentence of release should read: xxx a generic
version of Rimadyl(R) (Carpofen) 25, 75 and 100 mg Caplets (sted
xxx a generic version of Rimadyl(R) (Carpofen) 25, 50 and 75 mg
Caplets). The corrected release reads: IMPAX RECEIVES FDA APPROVAL
FOR GENERIC VERSION OF RIMADYL, A VETERINARY PRODUCT; FOURTH
APPROVAL IN 2005 IMPAX Laboratories, Inc. (NASDAQ:IPXLE) today
announced that the U.S. Food and Drug Administration (FDA) has
granted final approval to the Company's Abbreviated New Animal Drug
Application (ANADA) for a generic version of Rimadyl(R) (Carpofen)
25, 75 and 100 mg Caplets. Pfizer Animal Health markets Rimadyl for
the relief of pain and inflammation in dogs due to canine
arthritis, orthopedic and soft tissue surgery. Total U.S. sales of
Rimadyl were approximately $84 million in the 12 months ended
December 31, 2004, according to Market Dynamics. Sales of the
caplet dosage form were approximately $22 million. "We are very
pleased with this our first ANADA and our fourth approval in 2005,"
said Larry Hsu, Ph.D., IMPAX's President. "Rimadyl is the #1
prescribed canine NSAID in the world and we are pleased to add this
important product to our growing portfolio of products. Our generic
version should offer this growing segment of the companion animal
market a cost effective alternative to the brand." Additionally,
IMPAX has recently signed an agreement to market this product
through Vedco Inc., a leading national distributor of products to
the veterinary market. Vedco offers a full line of affordable
product solutions for today's veterinary clinician through a
nationwide network of veterinary wholesale distributors. This
agreement is consistent with the Company's strategy of using
strategically appropriate marketing partnerships to fully leverage
its technology platform. It is expected that Vedco will begin
marketing this product immediately. 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, possible adverse effects resulting
from IMPAX's delay in filing its 2004 Form 10-K including possible
delisting from the NASDAQ National Market, 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.
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