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Qualitest Pharmaceuticals Receives FDA Approval for Toresmide Tablets (Generic Demadex(r)) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease


3/24/2011 6:58:46 AM

HUNTSVILLE, Ala., March 24, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Toresmide tablets (generic Demadex®)in 5 mg, 10 mg, 20 mg and 100 mg strengths. Toresmide tablets are indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease, and for the treatment of hypertension alone or in combination with other antihypertensive agents.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com).

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, the business combination between Endo and Qualitest, Endos and Qualitests financial position, results of operations, market position, product development and business strategy, as well as estimates of Endos future total revenues, future expenses, future net income and future earnings per share. Statements including words such as believes, expects, anticipates, intends, estimates, plan, will, may intend, guidance or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect the business combination of the companies, future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to: the risk that the operations of Endo and Qualitest will not be integrated successfully; Endos ability to successfully develop, commercialize and market new products; timing and results of pre-clinical or clinical trials on new products; Endos and Qualitests ability to obtain regulatory approval of any of their respective pipeline products; competition for the business of Endos and Qualitests branded and generic products, and in connection with its acquisition of rights to intellectual property assets; market acceptance of our future products; government regulation of the pharmaceutical industry; Endos dependence on a small number of products; Endos dependence on outside manufacturers for the manufacture of a majority of its products; Endos dependence on third parties to supply raw materials and to provide services for certain core aspects of its business; new regulatory action or lawsuits relating to Endos or Qualitests use of narcotics in many of its core products; Endos and Qualitests exposure to product liability claims, market withdrawals and product recalls and the possibility that Endo may not be able to adequately insure itself; the successful efforts of manufacturers of branded pharmaceuticals to use litigation and legislative and regulatory efforts to limit the use of generics and certain other products; Endos ability to successfully implement its acquisition and in-licensing strategy; regulatory or other limits on the availability of controlled substances that constitute the active ingredients of some of its products and products in development; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by third parties or the government, and the performance of indemnitors with respect to claims for which we have been indemnified; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of its total revenues; a determination by a regulatory agency that Endo is engaging or has engaged in inappropriate sales or marketing activities, including promoting the off-label use of its products, the risk that demand for and acceptance of our products or services may be reduced; the risk of changes in governmental regulations; the impact of economic conditions; the impact of competition and pricing and other risks and uncertainties, including those detailed from time to time in Endos periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption RISK FACTORS" in our periodic and current reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Qualitest Pharmaceuticals


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