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IMPAX Receives FDA Approval for Generic Claritin Reditabs.


Business Editors/Health/Medical Writers

HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 30, 2003

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 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  (ANDA ANDA
abbr.
abbreviated new drug application
) for a generic version of Claritin(R) Reditabs(R) (Loratadine Orally Disintegrating Tablets) 10 mg. Schering Plough Corporation (NYSE NYSE

See: New York Stock Exchange
:SGP SGP Singapore (ISO Country code)
SGP Schering-Plough (stock symbol)
SGP Stability and Growth Pact
SGP Southern Great Plains
SGP Staatkundig Gereformeerde Partij
SGP Speedway Grand Prix
) markets Claritin Reditabs as an over-the-counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) drug for the relief of symptoms of seasonal allergic rhinitis seasonal allergic rhinitis,
n See hay fever.

seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis.
 (hay fever). According to NDCHealth, U.S. prescription and OTC sales of Claritin Reditabs were over $175 million for the 12 months ended July 31, 2003.

"This is our seventh ANDA approval this year," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President. "We are pleased to add Loratadine Orally Disintegrating Tablets to our growing product line and continue to work diligently with our partner on the launch of this product."

IMPAX currently has 18 applications pending at the FDA, including four tentatively approved, which address approximately $7 billion in U.S. branded product sales for the twelve months ended July 31, 2003. Fifteen 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 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:Sep 30, 2003
Words:525
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