Noven to Resume Shipment of Vivelle-Dot.Business Editors/Health/Medical Writers MIAMI--(BUSINESS WIRE)--Nov. 19, 2003 Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) today provided an update on the status of its Vivelle-Dot(R) product. On October 30, Noven announced that Novartis Pharmaceuticals Corporation (Novartis) was expected to recall a quantity of Noven's Vivelle-Dot product, and that Noven had suspended sus·pend v. sus·pend·ed, sus·pend·ing, sus·pends v.tr. 1. To bar for a period from a privilege, office, or position, usually as a punishment: suspend a student from school. shipments of Vivelle-Dot and Estradot(R) pending product testing and analysis to determine the scope of the issue. Following an analysis of current data, the quality teams of Noven and Novartis have agreed that the probable cause Apparent facts discovered through logical inquiry that would lead a reasonably intelligent and prudent person to believe that an accused person has committed a crime, thereby warranting his or her prosecution, or that a Cause of Action has accrued, justifying a civil lawsuit. of the issue is related to the use of certain rolls of patch backing material provided by a raw material supplier. Novartis has decided to recall all Vivelle-Dot product containing the suspect patch backing material, and has authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: Noven to immediately resume shipment of Vivelle-Dot and Estradot product that does not contain this material. Noven is continuing to conduct product testing and analysis. Noven estimates that the decision to recall all product containing the suspect backing material will reduce Noven's net income for the 2003 fourth quarter by approximately $600,000. "We are pleased to receive authorization to ship," said Robert C. Strauss, Noven's President, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. & Chairman, "and that there has been no interruption INTERRUPTION. The effect of some act or circumstance which stops the course of a prescription or act of limitation's. 2. Interruption of the use of a thing is natural or civil. in trade supplies as a result of this issue." About Noven Noven Pharmaceuticals, Inc., headquartered in Miami, Florida “Miami” redirects here. For the Native American tribe, see Miami tribe. Miami is a major city in southeastern Florida, in the United States. It is the county seat of Miami-Dade County. Miami is a gamma world city with an estimated population of 404,048. , is a leading developer of advanced transdermal transdermal /trans·der·mal/ (-der´m'l) entering through the dermis, or skin, as in administration of a drug via ointment or patch. trans·der·mal adj. Through or by way of the skin. drug delivery technologies and prescription transdermal products. Together with Novartis, Noven owns a women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems transdermal delivery system: see skin patch. (including Vivelle-Dot(R), licensed to Novogyne, and Estradot(R), licensed to Novartis Pharma AG) and combination estrogen/progestin transdermal delivery systems (including CombiPatch(R), licensed to Novogyne, and Estalis, licensed to Novartis Pharma AG). With a range of additional products in development, Noven is committed to becoming the world's premier transdermal drug delivery company. For additional information on Noven, visit http://www.noven.com. Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. When used in this press release the words "current," "estimates," "probable," and similar expressions identify certain of such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven Pharmaceuticals, Inc. (the "Company") and are subject to a number of risks and uncertainties that are subject to change based on factors which are, in many instances, beyond the Company's control, including but not limited to risks and uncertainties associated with: the timing and magnitude of any expected or unexpected product recalls; the impact of the recalls or related issues on Novartis' strategy for the commercialization of the Company's products; the timing and magnitude of any additional detected or undetected product stability failures or other product defects involving any of the Company's products; the possibility that the analysis of the cause of the Vivelle-Dot stability failure may prove inaccurate, incomplete or otherwise incorrect; the possibility that the Company's estimates of the impact of future returns and charges may prove inaccurate, incomplete or otherwise incorrect; the impact of detected or undetected product stability failures or other product defects on the Company's ability to estimate its reserves for sales returns and other accounting consequences associated therewith there·with adv. 1. With that, this, or it. 2. In addition to that. 3. Archaic Immediately thereafter. Adv. 1. ; the impact of expected and unexpected product recalls on the market for and competitive positioning of the Company's products; regulatory actions or supervision that may be taken against the Company by the 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. or other regulators in light of the announced and expected product recalls, whether relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's manufacturing processes, suppliers, commercialized products, products in development or otherwise, and any costs associated therewith; and the Company's success at managing the risks relating to the foregoing. In addition to the risks and factors identified above, reference is also made to the other risks and factors detailed in reports filed by the Company with the Securities and Exchange Commission. The Company cautions that the foregoing list of factors is not exhaustive. |
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