Impax labs (NASDAQ:IPXLE)
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From Jan 2020 to Jan 2025
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, 50 and 75
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.