Sepracor Receives Notice of Second Abbreviated New Drug Application Submission for Levalbuterol Hydrochloride Inhalation Solution.MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR SEPR Senior Enlisted Performance Report ) today announced that it has been notified 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 received an 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 ) from Dey, L.P. for a generic version of levalbuterol hydrochloride levalbuterol hydrochloride Xopenex Pharmacologic class: Adrenergic beta2 agonist Therapeutic class: Bronchodilator Pregnancy risk category C Actioninhalation solution. Dey's submission includes a Paragraph IV certification alleging that Sepracor's patents listed in the Orange Book for XOPENEX(R) inhalation solution are invalid, unenforceable or not infringed by Dey's proposed product. Sepracor announced in September 2005 that the FDA had received an ANDA from Breath Limited for levalbuterol hydrochloride inhalation solution.Sepracor owns five U.S. patents on methods of treating patients with levalbuterol, with patent terms expiring between 2010 and 2013. Sepracor's sixth patent covering stable levalbuterol formulations expires in 2021. Sepracor believes that its patent position for XOPENEX is strong and the company is prepared to vigorously defend its patent rights. About Sepracor Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . The company's commercialization efforts are carried out by its U.S.-based, primary care and specialty-oriented sales force, which is comprised of more than 1,400 sales professionals. Sepracor's corporate headquarters are located in Marlborough, Massachusetts Marlborough is a city in Middlesex County, Massachusetts, United States. The population was 36,255 at the 2000 census. The name of this town is sometimes spelled as Marlboro, rather than Marlborough, which is the official spelling. . Forward-Looking Statement 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. This news release contains forward-looking statements that involve risks and uncertainties, including statements regarding potential generic competition and our responses thereto, and the strength of Sepracor's patent position. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are regulatory, legal and political conditions affecting the pharmaceutical industry, and certain other factors that may affect future operating results and are detailed in the company's quarterly report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2005 filed with the Securities and Exchange Commission. In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release. XOPENEX is a registered trademark of Sepracor Inc. For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com. |
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