IMPAX Receives FDA Approval for Generic Version of SALAGEN(R) Tablets; Global Pharmaceuticals Division to Launch.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 approval of 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 SALAGEN(R) (Pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). Hydrochlorine) 5 and 7.5 mg Tablets. MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) Pharma, Inc. markets SALAGEN Tablets for the treatment of symptoms of dry mouth from salivary gland salivary gland Any of the organs that secrete saliva. Three pairs of major glands secrete saliva into the mouth through distinct ducts: the parotid glands (the largest), between the ear and the back of the lower jaw; the submaxillary glands, along the side of the lower jaw; hypofunction caused by radiotherapy for cancer of the head and neck; and for the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome Sjö·gren's syndrome n. A syndrome occurring in menopausal women, characterized by keratoconjunctivitis sicca, dryness of mucous membranes, telangiectasias or purpuric spots on the face, and bilateral parotid enlargement; it is often associated with . Total brand and generic sales of SALAGEN in the U.S. were $25 million for the 12 months ended December 31, 2005, according to Wolters Kluwer Health. IMPAX's Global Pharmaceuticals division intends to begin marketing this product in the near future. "This is our first approval this year," said Larry Hsu, Ph.D., IMPAX's President. "We are very pleased to see that our efforts continue to culminate in new product approvals. 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, 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, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, and its Form 10-K for 2005, 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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