Healthcare Industry News: Sjogren's syndrome
News Release - April 5, 2006
IMPAX Receives FDA Approval for Generic Version of SALAGEN(R) TabletsGlobal Pharmaceuticals Division to Launch
HAYWARD, Calif.--(HSMN NewsFeed)--April 5, 2006--IMPAX Laboratories, Inc. (NASDAQ:IPXL ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of SALAGENŽ (Pilocarpine Hydrochlorine) 5 and 7.5 mg Tablets. MGI Pharma, Inc. markets SALAGEN Tablets for the treatment of symptoms of dry mouth from salivary gland 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. 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 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, 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.
Source: IMPAX Laboratories
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