LYCOS RETRIEVER
Niaspan: Products
built 647 days ago
There may be other drugs not listed that can affect Niaspan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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Three niacin products are available: an over-the-counter immediate-release formulation, an extended-release prescription formulation (Niaspan), and several over-the-counter sustained-release preparations. The LDL-C-lowering and HDL-C-raising efficacy of the sustained-release products is modest compared with the immediate-release products. Niaspan at its maximum daily dose of 2 g/d reduces LDL-C by about 15%. These products ... differ importantly in the side effects they can produce (see below).
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Kos received a boost for potential sales of Niaspan in October when the FDA approved a supplemental application of the product for increasing HDL cholesterol in patients with dyslipidemia, the second product to obtain approval for HDL treatment. Advanced clinical studies showed that Niaspan raised HDL up to 26 percent while it lowered LDL up to 17 percent, and TG up to 35 percent.
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Certain statements in this press release, including statements relating to the expected continued growth of the Niaspan product, are forward-looking and are subject to risks and uncertainties. These risks and uncertainties include regulatory risk associated with an application for approval by the FDA, the ability of the Company to maintain the size of its sales force, the Company's ability to market its Niaspan product, the Company's ability to meet the conditions necessary to obtain funding under its funding arrangements, the validity, scope and enforceability of its patents, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks. A more detailed discussion of risks attendant to the forward- looking statements included in this press release is set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the period ended December 31, 2001, filed with the Securities and Exchange Commission (SEC), and in other reports and documents filed with the SEC.
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Abbott submitted its New Drug Application to the Food and Drug Administration for a fixed-dose combination (Simcor) of Niaspan® (extended-release niacin) and simvastatin. This product seeks to target multiple lipid parameters in a single pill.
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