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IMPAX Receives Final FDA Approval for Generic Version of Dantrium; Global Division to Launch Immediately.


HAYWARD, Calif. -- IMPAX Laboratories, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:IPXL) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted final approval to the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  for a generic version of Dantrium(R) (Dantrolene Sodium dantrolene sodium
(dantrōlēn),
n brand name: Dantrium;
drug class: skeletal muscle relaxant, direct acting;
action: interferes with intracellular release of calcium necessary to initiate contraction;
uses:
) 25, 50 and 100 mg Capsules. Proctor and Gamble Pharmaceuticals markets Dantrium for the treatment of spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2).

spas·tic·i·ty
n.
1. A spastic state or condition.

2. Spastic paralysis.
 in stroke, multiple sclerosis, cerebral palsy cerebral palsy (sərē`brəl pôl`zē), disability caused by brain damage before or during birth or in the first years, resulting in a loss of voluntary muscular control and coordination.  and spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
. U.S. sales of Dantrium 25, 50 and 100 mg Capsules were approximately $14 million in the 12 months ended December 31, 2004, according to NDCHealth. IMPAX's Global Pharmaceuticals division intends to begin marketing this product immediately.

"This is our second approval, and first final approval, this year," said Larry Hsu, Ph.D., IMPAX's President. "We are very pleased to see that our efforts are culminating in new product approvals. As the first generic version of Dantrium approved by the FDA, this product should offer both patients and payors a cost-effective alternative to the brand."

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, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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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Publication:Business Wire
Date:Mar 2, 2005
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